Effect of Fufang E'Jiao Jiang on Hierarchical Composite Clinical Benefit and Health-related Quality of Life in ICU Survivors After ICU Discharge: a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial (LIFT)
This study aims to evaluate the effects of Fufang E'jiao Jiang on clinical outcomes, health-related quality of life, and functional recovery in survivors of critical illness following intensive care unit (ICU) discharge.This multicenter, randomized, double-blind, placebo-controlled trial will enroll 246 participants who will be randomly assigned in a 1:1 ratio to receive either Fufang E'jiao Jiang or matching placebo. Participants will receive 20 mL orally three times daily for 90 days, alongside standard post-ICU rehabilitation and supportive care.The primary outcome is a prespecified hierarchical composite endpoint assessed within 90 days after randomization and analyzed using the win ratio method. The components are evaluated in the following order of clinical priority: (1) all-cause mortality within 90 days; (2) unplanned all-cause readmission within 90 days; and (3) change from baseline in the EQ-5D-5L utility index at day 90. Secondary outcomes include exercise tolerance, frailty, cognitive function, fatigue, anxiety and depression, sleep quality assessed by wrist actigraphy and the Pittsburgh Sleep Quality Index (PSQI), appetite, handgrip strength, body composition, and selected biochemical, hematologic, and iron metabolism-related indicators. The trial aims to provide clinical evidence regarding the potential role of Fufang E'jiao Jiang in supporting recovery and improving health-related outcomes among survivors of critical illness after ICU discharge.
연구 개요
상세 설명
Post-intensive care syndrome is common among survivors of critical illness and is associated with impaired physical function, cognitive dysfunction, psychological symptoms, reduced quality of life, and increased health care utilization after intensive care unit (ICU) discharge. Current post-ICU rehabilitation strategies remain limited, and effective pharmacologic interventions are lacking. Fufang E'jiao Jiang is a traditional Chinese medicine preparation that has been used to improve fatigue, nutritional status, and functional recovery in relevant clinical settings. Based on its traditional indications and existing pharmacologic evidence, it may have potential value in supporting recovery among survivors of critical illness after ICU discharge. This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the efficacy and safety of Fufang E'jiao Jiang in adult survivors of critical illness after ICU discharge. A total of 246 participants will be enrolled and randomly assigned in a 1:1 ratio to receive either Fufang E'jiao Jiang or matching placebo. Study treatment will begin after ICU discharge once enteral nutrition has been initiated. Participants in both groups will receive standard post-ICU rehabilitation and supportive care. The investigational group will receive Fufang E'jiao Jiang, 20 mL orally three times daily for 90 consecutive days. The control group will receive a matching placebo with the same dosing schedule, appearance, packaging, color, and taste but without the active ingredients of Fufang E'jiao Jiang. The primary outcome is a prespecified hierarchical composite endpoint evaluated within 90 days after randomization and analyzed using the win ratio method. The components will be compared sequentially according to their predefined clinical priority: (1) all-cause mortality within 90 days after randomization; (2) unplanned all-cause readmission within 90 days after randomization; and (3) change from baseline in the EQ-5D-5L utility index at day 90, using a prespecified clinically meaningful threshold. The primary treatment effect will be summarized using a single win ratio. Secondary outcomes will assess multiple domains of post-ICU recovery, including physical function, frailty, cognitive function, fatigue, psychological health, sleep quality, appetite, nutritional status, body composition, and selected laboratory indicators. Physical and functional assessments will include the 6-minute walk test distance, Clinical Frailty Scale score, Montreal Cognitive Assessment score, Fatigue Severity Scale score, Hospital Anxiety and Depression Scale score, and handgrip strength. Sleep-related outcomes will be assessed using both objective and subjective measurements. Objective sleep parameters, including total sleep time, sleep efficiency, and wake after sleep onset, will be recorded using a wearable sleep wristband (actigraphy). Subjective sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI). Body composition will be assessed using the Nutrilab body composition analysis system. The assessed parameters will include body fat percentage, fat mass, skeletal muscle mass, and fat-free mass. Biochemical and hematologic assessments will include hemoglobin concentration, albumin, prealbumin, C-reactive protein, creatinine, blood urea nitrogen, red blood cell count, absolute lymphocyte count, and white blood cell count. Hemoglobin concentration and blood cell counts will be assessed using whole-blood hematological analysis. The percentage of HLA-DR-positive monocytes will be assessed in peripheral blood using flow cytometry. Additional hematologic and iron metabolism-related assessments will include absolute reticulocyte count, reticulocyte hemoglobin content (RET-He or CHr), serum ferritin concentration, and transferrin saturation (TSAT). TSAT will be calculated using serum iron concentration and total iron-binding capacity, with the latter measured directly or derived from transferrin concentration using a validated laboratory method. Plasma growth differentiation factor 15 (GDF15) concentration will also be assessed. Sleep quality and body composition will be evaluated at baseline, day 30, and day 90 after randomization. The selected biochemical, hematologic, and iron metabolism-related indicators will be assessed at baseline and day 90 after randomization. The trial is intended to generate clinical evidence regarding the role of Fufang E'jiao Jiang in supporting functional recovery, health-related quality of life, and selected hematologic, nutritional, and metabolic outcomes among survivors of critical illness after ICU discharge.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Liang Tan
- 전화번호: +86-158-2354-0630
- 이메일: liangtan@tmmu.edu.cn
연구 장소
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Chongqing, 중국, China
- Chongqing Iron and Steel General Hospital
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연락하다:
- zhigao He
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Chongqing, 중국, China
- Chongqing University Affiliated Jiangjin Hospital (Chongqing Jiangjin District Central Hospital)
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연락하다:
- jun Yang
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Chongqing, 중국, China
- Dianjiang County People's Hospital of Chongqing
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연락하다:
- jianbin Huang
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Chongqing, 중국, China
- Hechuan Hospital of Traditional Chinese Medicine
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연락하다:
- changyuan Zhou
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Chongqing, 중국, China
- Jiangsu Province Hospital of Chinese Medicine Chongqing Hospital (Chongqing Yongchuan District Hospital of Traditional Chinese Medicine)
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연락하다:
- ke Li
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Chongqing, 중국, China
- No. 958 Hospital of Chinese PLA Land Force
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연락하다:
- Xuemei Yang
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Chongqing, 중국, China
- People's Hospital of Shapingba District
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연락하다:
- Shengqing He
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Chongqing, 중국, China
- PLA Army Characteristic Medical Center
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연락하다:
- hao Tang
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Chongqing, 중국, China
- The First Affiliated Hospital of Army Medical University
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부수사관:
- Liang Tan, MD
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부수사관:
- Yonghui Zhang, MB
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부수사관:
- Yan Zhang, MB
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부수사관:
- Ying Cao, MB
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부수사관:
- Weiguang Zhang, MM
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부수사관:
- Dongfang Yang, MM
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부수사관:
- Lenv Gao, MD
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연락하다:
- Liang Tan
- 전화번호: +86-158-2354-0630
- 이메일: liangtan@tmmu.edu.cn
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수석 연구원:
- Changlin Yin, MD
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부수사관:
- Lan Cheng, MM
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부수사관:
- Ya Wang, MM
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Chongqing, 중국, China
- The People's Hospital of Rongchang District
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연락하다:
- dan Li
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Chongqing, 중국, China
- The Second Affiliated Hospital of Chongqing Medical University
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연락하다:
- chenyang Duan
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Jiangsu
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Nanjing, Jiangsu, 중국, China
- Eastern Theater Command General Hospital
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연락하다:
- Lu Ke
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Sichuan
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Panzhihua, Sichuan, 중국, China
- Panzhihua Central Hospital
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연락하다:
- xiaodong Deng
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Provision of informed consent
- Age 18 years or older
- Expected ICU discharge within 24 hours
- APACHE II score of 15 or higher at ICU admission
- Received mechanical ventilation for at least 6 hours during the current ICU stay
- Duration of the current ICU stay of more than 48 hours and no more than 28 days
- Enteral nutrition has been initiated
- Able to cooperate with study-related assessments and follow-up, including simple bedside activities such as sitting, standing, or short-distance walking independently or with assistance.
Exclusion Criteria:
- Expected death or withdrawal of life-sustaining treatment within 48 hours after ICU discharge
- Severe liver failure (Child-Pugh class C) at ICU discharge
- Chronic kidney disease with creatinine clearance less than 40 mL/min at ICU discharge
- Pregnant or breastfeeding
- Unable to walk independently before ICU admission, except those able to walk independently with a walking aid
- Acute-phase traumatic brain injury, primary cerebrovascular disease, brain tumor, or intracranial infection
- Primary cognitive impairment, including Alzheimer's disease, vascular dementia, hydrocephalus, or other severe central nervous system disease
- History of psychiatric or psychological disorders such as depression, anxiety, or schizophrenia
- History of cardiopulmonary arrest
- Lower limb injury, systemic neuromuscular disease, or spinal condition that may affect outcome assessment
- Current use of other Chinese herbal medicines or proprietary Chinese medicines intended to tonify qi and nourish blood
- Known allergy to Fufang E'jiao Jiang or any of its components
- Active gastrointestinal bleeding
- Body mass index less than 16.0 kg/m² or 40.0 kg/m² or higher
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Fufang Ejiao Jiang
Participants will receive Fufang Ejiao Jiang, 20 mL orally three times daily for 90 consecutive days |
Oral liquid, 20 mL by mouth three times daily for 90 consecutive days. |
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위약 비교기: placebo
Participants will receive a matching placebo, 20 mL orally three times daily for 90 consecutive days |
Oral liquid placebo, 20 mL by mouth three times daily for 90 consecutive days. The placebo is matched to Fufang Ejiao Jiang in appearance, packaging, color, and taste and contains no active ingredients of Fufang Ejiao Jiang Other Name: |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Win Ratio for the 90-Day Hierarchical Composite Outcome
기간: From randomization through day 90
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The primary outcome is a single prespecified hierarchical composite endpoint analyzed using the win ratio method. Participants from the two randomized groups will be compared pairwise according to the following clinical priority hierarchy: (1) all-cause mortality within 90 days after randomization; (2) unplanned all-cause readmission within 90 days after randomization; and (3) change from baseline in the EQ-5D-5L utility index at day 90. Comparisons will proceed to the next component when no winner is determined at the preceding level. The primary treatment effect will be expressed as a single win ratio, calculated as the ratio of winning to losing pairs. The three components constitute one hierarchical composite endpoint rather than three separate primary outcome measures. |
From randomization through day 90
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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6-minute walk test distance
기간: At baseline, 30 days after randomization, and 90 days after randomization
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Exercise tolerance assessed using the 6-minute walk test |
At baseline, 30 days after randomization, and 90 days after randomization
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Clinical Frailty Scale score
기간: At baseline, 30 days after randomization, and 90 days after randomization
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Frailty assessed using the Clinical Frailty Scale |
At baseline, 30 days after randomization, and 90 days after randomization
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Montreal Cognitive Assessment score
기간: At baseline, 30 days after randomization, and 90 days after randomization
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Cognitive function assessed using the Montreal Cognitive Assessment |
At baseline, 30 days after randomization, and 90 days after randomization
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Fatigue Severity Scale score
기간: At baseline, 30 days after randomization, and 90 days after randomization
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Fatigue assessed using the Fatigue Severity Scale |
At baseline, 30 days after randomization, and 90 days after randomization
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Hospital Anxiety and Depression Scale score
기간: At baseline, 30 days after randomization, and 90 days after randomization
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Psychological symptoms assessed using the Hospital Anxiety and Depression Scale |
At baseline, 30 days after randomization, and 90 days after randomization
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Total Sleep Time Measured by Wrist Actigraphy
기간: At baseline, 30 days after randomization, and 90 days after randomization.
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Total sleep time will be assessed using a wearable sleep wristband (actigraphy) and reported in minutes. |
At baseline, 30 days after randomization, and 90 days after randomization.
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Sleep Efficiency Measured by Wrist Actigraphy
기간: At baseline, 30 days after randomization, and 90 days after randomization.
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Sleep efficiency will be assessed using a wearable sleep wristband (actigraphy) and reported as a percentage. |
At baseline, 30 days after randomization, and 90 days after randomization.
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Wake After Sleep Onset Measured by Wrist Actigraphy
기간: At baseline, 30 days after randomization, and 90 days after randomization.
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Wake after sleep onset (WASO) will be assessed using a wearable sleep wristband (actigraphy) and reported in minutes. |
At baseline, 30 days after randomization, and 90 days after randomization.
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Global Score on the Pittsburgh Sleep Quality Index (PSQI)
기간: At baseline, 30 days after randomization, and 90 days after randomization.
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Subjective sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The global score ranges from 0 to 21, with higher scores indicating poorer sleep quality. |
At baseline, 30 days after randomization, and 90 days after randomization.
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Appetite
기간: At baseline, 30 days after randomization, and 90 days after randomization
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Appetite will be assessed using the Simplified Nutritional Appetite Questionnaire (SNAQ), a 4-item self-administered instrument covering appetite, feelings of fullness, taste of food, and number of meals per day. The total score ranges from 4 to 20; a score of 14 or lower indicates a significant risk of at least 5% weight loss within 6 months, with lower scores indicating poorer appetite. |
At baseline, 30 days after randomization, and 90 days after randomization
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Handgrip strength
기간: At baseline, 30 days after randomization, and 90 days after randomization
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Muscle strength assessed by handgrip dynamometry |
At baseline, 30 days after randomization, and 90 days after randomization
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Body Fat Percentage Measured by Nutrilab Body Composition Analysis
기간: At baseline, day 30, and day 90 after randomization.
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Body fat percentage will be measured using the Nutrilab body composition analysis system and reported as the percentage of total body weight consisting of fat mass. |
At baseline, day 30, and day 90 after randomization.
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Fat Mass Measured by Nutrilab Body Composition Analysis
기간: At baseline, day 30, and day 90 after randomization.
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Total body fat mass will be measured using the Nutrilab body composition analysis system and reported in kilograms. |
At baseline, day 30, and day 90 after randomization.
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Skeletal Muscle Mass Measured by Nutrilab Body Composition Analysis
기간: At baseline, day 30, and day 90 after randomization.
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Skeletal muscle mass will be measured using the Nutrilab body composition analysis system and reported in kilograms. |
At baseline, day 30, and day 90 after randomization.
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Fat-Free Mass Measured by Nutrilab Body Composition Analysis
기간: At baseline, day 30, and day 90 after randomization.
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Fat-free mass will be measured using the Nutrilab body composition analysis system and reported in kilograms. |
At baseline, day 30, and day 90 after randomization.
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Hemoglobin Concentration
기간: At baseline and day 90 after randomization.
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Hemoglobin concentration will be measured in whole blood using routine complete blood count (CBC) analysis and reported in g/L. |
At baseline and day 90 after randomization.
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Albumin Concentration
기간: At baseline and day 90 after randomization.
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Albumin concentration will be measured by routine clinical laboratory analysis and reported in g/L. |
At baseline and day 90 after randomization.
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Prealbumin Concentration
기간: At baseline and day 90 after randomization.
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Prealbumin concentration will be measured by routine clinical laboratory analysis and reported in mg/L. |
At baseline and day 90 after randomization.
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C-Reactive Protein Concentration
기간: At baseline and day 90 after randomization.
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C-reactive protein (CRP) concentration will be measured by routine clinical laboratory analysis and reported in mg/L. |
At baseline and day 90 after randomization.
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Creatinine Concentration
기간: At baseline and day 90 after randomization.
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Creatinine concentration will be measured by routine clinical laboratory analysis and reported in µmol/L. |
At baseline and day 90 after randomization.
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Blood Urea Nitrogen Concentration
기간: At baseline and day 90 after randomization.
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Blood urea nitrogen (BUN) concentration will be measured by routine clinical laboratory analysis and reported in mmol/L. |
At baseline and day 90 after randomization.
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Red Blood Cell Count
기간: At baseline and day 90 after randomization.
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Red blood cell count will be measured in whole blood using routine complete blood count (CBC) analysis and reported in 10^12 cells/L. |
At baseline and day 90 after randomization.
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Absolute Lymphocyte Count
기간: At baseline and day 90 after randomization.
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Absolute lymphocyte count will be measured in whole blood using routine hematological analysis and reported in 10^9 cells/L. |
At baseline and day 90 after randomization.
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White Blood Cell Count
기간: At baseline and day 90 after randomization.
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White blood cell count will be measured in whole blood using routine complete blood count (CBC) analysis and reported in 10^9 cells/L. |
At baseline and day 90 after randomization.
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Percentage of HLA-DR-Positive Cells
기간: At baseline and day 90 after randomization.
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The percentage of HLA-DR-positive monocytes will be assessed in peripheral blood using flow cytometry. HLA-DR-positive monocytes will be quantified as a percentage of the total monocyte population, with higher percentages indicating a greater proportion of monocytes expressing HLA-DR. |
At baseline and day 90 after randomization.
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Absolute Reticulocyte Count
기간: At baseline and day 90 after randomization.
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Absolute reticulocyte count will be measured in peripheral whole blood using an automated hematology analyzer and reported in 10^9 cells/L. |
At baseline and day 90 after randomization.
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Reticulocyte Hemoglobin Content (RET-He or CHr)
기간: At baseline and day 90 after randomization.
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Reticulocyte hemoglobin content will be measured in peripheral whole blood using an automated hematology analyzer and reported in picograms (pg) per reticulocyte. The parameter will be reported as reticulocyte hemoglobin equivalent (RET-He) or reticulocyte hemoglobin content (CHr), depending on the analyzer used. |
At baseline and day 90 after randomization.
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Serum Ferritin Concentration
기간: At baseline and day 90 after randomization.
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Serum ferritin concentration will be measured using a clinical laboratory immunoassay and reported in ng/mL. |
At baseline and day 90 after randomization.
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Transferrin Saturation (TSAT)
기간: At baseline and day 90 after randomization.
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Transferrin saturation (TSAT) will be calculated from serum iron concentration and total iron-binding capacity (TIBC) using the formula: TSAT (%) = [serum iron / TIBC] × 100, with both measurements expressed in the same units. TIBC will be measured directly or calculated from serum transferrin concentration using the validated laboratory-specific method. TSAT will be reported as a percentage. |
At baseline and day 90 after randomization.
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Plasma Growth Differentiation Factor 15 (GDF15) Concentration
기간: At baseline and day 90 after randomization.
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Plasma growth differentiation factor 15 (GDF15) concentration will be measured using a validated immunoassay and reported in pg/mL. |
At baseline and day 90 after randomization.
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
- Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.
- Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.
- Iwashyna TJ, Ely EW, Smith DM, Langa KM. Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA. 2010 Oct 27;304(16):1787-94. doi: 10.1001/jama.2010.1553.
- Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.
- Li Y, He H, Yang L, Li X, Li D, Luo S. Therapeutic effect of Colla corii asini on improving anemia and hemoglobin compositions in pregnant women with thalassemia. Int J Hematol. 2016 Nov;104(5):559-565. doi: 10.1007/s12185-016-2069-0. Epub 2016 Jul 25.
- Greysen SR, Stijacic Cenzer I, Auerbach AD, Covinsky KE. Functional impairment and hospital readmission in Medicare seniors. JAMA Intern Med. 2015 Apr;175(4):559-65. doi: 10.1001/jamainternmed.2014.7756.
- Solverson KJ, Grant C, Doig CJ. Assessment and predictors of physical functioning post-hospital discharge in survivors of critical illness. Ann Intensive Care. 2016 Dec;6(1):92. doi: 10.1186/s13613-016-0187-8. Epub 2016 Sep 20.
- Pocock SJ, Ariti CA, Collier TJ, Wang D. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J. 2012 Jan;33(2):176-82. doi: 10.1093/eurheartj/ehr352. Epub 2011 Sep 6.
- Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.
- Schetz M, De Jong A, Deane AM, Druml W, Hemelaar P, Pelosi P, Pickkers P, Reintam-Blaser A, Roberts J, Sakr Y, Jaber S. Obesity in the critically ill: a narrative review. Intensive Care Med. 2019 Jun;45(6):757-769. doi: 10.1007/s00134-019-05594-1. Epub 2019 Mar 19.
- WHO Expert Consultation. Appropriate body-mass index for Asian populations and its implications for policy and intervention strategies. Lancet. 2004 Jan 10;363(9403):157-63. doi: 10.1016/S0140-6736(03)15268-3.
- Luo N, Liu G, Li M, Guan H, Jin X, Rand-Hendriksen K. Estimating an EQ-5D-5L Value Set for China. Value Health. 2017 Apr;20(4):662-669. doi: 10.1016/j.jval.2016.11.016. Epub 2017 Feb 9.
- Zhang Y, Ye T, Hong Z, Gong S, Zhou X, Liu H, Qian J, Qu H. Pharmacological and transcriptome profiling analyses of Fufang E'jiao Jiang during chemotherapy-induced myelosuppression in mice. J Ethnopharmacol. 2019 Jun 28;238:111869. doi: 10.1016/j.jep.2019.111869. Epub 2019 Apr 9.
- Li Y, Zhang Z, Yang L, Li X, Zhou J, Li D, Luo S. Colla corii asini might upregulate ZNF471 and THOC5 by KRAB domain-containing zinc-finger protein pathway and THO complex subunit 5 pathway to improve anemia of pregnant women with beta-thalassemia. Ann Hematol. 2019 Aug;98(8):1813-1826. doi: 10.1007/s00277-019-03710-1. Epub 2019 May 16.
- Shi WB, Wang ZX, Liu HB, Jia YJ, Wang YP, Xu X, Zhang Y, Qi XD, Hu FD. Study on the mechanism of Fufang E'jiao Jiang on precancerous lesions of gastric cancer based on network pharmacology and metabolomics. J Ethnopharmacol. 2023 Mar 25;304:116030. doi: 10.1016/j.jep.2022.116030. Epub 2022 Dec 20.
- Hrobjartsson A, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Chan AW. SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials. BMJ. 2025 Apr 28;389:e081660. doi: 10.1136/bmj-2024-081660.
- Lui KY, Luo G, Li S, Song X, Qian X, Dou R, Li L, Guan X, Cai C. Incidence and risk factors of Post-intensive care syndrome (PICS) in surgical ICU survivors: a prospective Chinese cohort study. BMC Public Health. 2024 Nov 26;24(1):3277. doi: 10.1186/s12889-024-20757-6.
- Thomas EM, Smith J, Curry A, Salsberry M, Ridgeway K, Hunt B, Desanto K, Falvey JR. Association of physical function with hospital readmissions among older adults: A systematic review. J Hosp Med. 2025 Mar;20(3):277-287. doi: 10.1002/jhm.13538. Epub 2024 Nov 4.
- Zhao M, Xiao M, Ying J, Qiu P, Wu H, Tan Q, Chen S, Zhang L, Shi S, Li G, Zhao Y, Lu F. Efficacy of Fufang E'jiao Jiang in the Treatment of Patients with Qi and Blood Deficiency Syndrome: A Real-World Prospective Multicenter Study with a Patient Registry. Evid Based Complement Alternat Med. 2023 Feb 3;2023:3179489. doi: 10.1155/2023/3179489. eCollection 2023.
- Dossett LA, Redhage LA, Sawyer RG, May AK. Revisiting the validity of APACHE II in the trauma ICU: improved risk stratification in critically injured adults. Injury. 2009 Sep;40(9):993-8. doi: 10.1016/j.injury.2009.03.004. Epub 2009 Jun 16.
- Wang W, Xin H, Wang M, Ma Q, Wang L, Kaleri NA, Wang Y, Li X. Transcriptomic Analysis Reveals the Molecular Mechanisms of Drought-Stress-Induced Decreases in Camellia sinensis Leaf Quality. Front Plant Sci. 2016 Mar 30;7:385. doi: 10.3389/fpls.2016.00385. eCollection 2016.
- Mao L, Kim K, Miao X. Sample size formula for general win ratio analysis. Biometrics. 2022 Sep;78(3):1257-1268. doi: 10.1111/biom.13501. Epub 2021 Jun 8.
- Fandino W, Dodd M, Kunst G, Clayton T. Efficient statistical analysis of trial designs: win ratio and related approaches for composite outcomes. Perioper Med (Lond). 2025 Jul 5;14(1):70. doi: 10.1186/s13741-025-00550-8.
- Ayenew T, Gete M, Gedfew M, Getie A, Afenigus AD, Edmealem A, Amha H, Alem G, Tiruneh BG, Messelu MA. Prevalence of Post-intensive care syndrome among intensive care unit-survivors and its association with intensive care unit length of stay: Systematic review and meta-analysis. PLoS One. 2025 May 8;20(5):e0323311. doi: 10.1371/journal.pone.0323311. eCollection 2025.
- Yue WL, Zhai PY, Mao JJ, Ma JF, Ren WL, Jiang T, Zhang B, Zhuang X, Feng J, Zang X, Qin G. Health and economic impacts of Vaccae vaccination incorporating active case finding in India and South Africa: a modelling study. BMJ Public Health. 2024 Sep 20;2(2):e001042. doi: 10.1136/bmjph-2024-001042. eCollection 2024 Dec.
- McPeake J, Bateson M, Christie F, Robinson C, Cannon P, Mikkelsen M, Iwashyna TJ, Leyland AH, Shaw M, Quasim T. Hospital re-admission after critical care survival: a systematic review and meta-analysis. Anaesthesia. 2022 Apr;77(4):475-485. doi: 10.1111/anae.15644. Epub 2021 Dec 29.
- Bakhru RN, Flores L, Cain JM, Province V, Fanning J, Rawal H, Bundy R, Obermiller CS, Moses A, Dharod A, Abdelfattah L, Hanchate A, Files DC. A Randomized Controlled Trial of a Post-ICU Telehealth Care Model (WFIT). Am J Respir Crit Care Med. 2025 Sep;211(9):1662-1670. doi: 10.1164/rccm.202411-2167OC.
- von Haehling S. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Jul 17;371(3):287. doi: 10.1056/NEJMc1406274. No abstract available.
- Rousseau AF, Minguet P, Colson C, Kellens I, Chaabane S, Delanaye P, Cavalier E, Chase JG, Lambermont B, Misset B. Post-intensive care syndrome after a critical COVID-19: cohort study from a Belgian follow-up clinic. Ann Intensive Care. 2021 Jul 29;11(1):118. doi: 10.1186/s13613-021-00910-9.
- Renner C, Jeitziner MM, Albert M, Brinkmann S, Diserens K, Dzialowski I, Heidler MD, Luck M, Nusser-Muller-Busch R, Sandor PS, Schafer A, Scheffler B, Wallesch C, Zimmermann G, Nydahl P. Guideline on multimodal rehabilitation for patients with post-intensive care syndrome. Crit Care. 2023 Jul 31;27(1):301. doi: 10.1186/s13054-023-04569-5.
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