- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07596043
Effect of High Versus Standard Protein Intake in Critically Ill Patients With Acute Kidney Injury Requiring Continuous Renal Replacement Therapy (PROTEIN-CRRT)
Effect of High Versus Standard Protein Intake in Critically Ill Patients With Acute Kidney Injury Requiring Continuous Renal Replacement Therapy: A Randomized Controlled Trial (PROTEIN-CRRT)
During critical illness, patients experience a hypercatabolic state. This hypercatabolic state causes muscle wasting in patients, resulting in intensive care unit acquired weakness (ICU-AW). ICU-AW is associated with prolonged mechanical ventilation (MV) weaning, extubating failure and extended length of stay. Previously recognized risk factors for ICU-AW include shock, sepsis, multiple organ failure, hyperglycemia, and prolonged exposure to corticosteroids, sedatives, or paralytic agents.
Critical illness is complicated by the development of acute kidney injury (AKI). AKI causes muscle wasting by increasing protein degradation and decreasing protein synthesis. Furthermore, patients with severe AKI often require renal replacement therapy (RRT), which contributes to additional protein loss. Studies have estimated that amino acid losses associated with RRT may range from 5 to 19 g/d, with greater losses observed in patients undergoing continuous renal replacement therapy (CRRT). AKI requiring CRRT has recently been proposed to contribute to an increased risk of ICU-AW.
Therefore, critically ill patients with AKI may require increased protein intake to compensate for these metabolic alterations. However, higher protein intake, particularly during the early acute phase of critical illness, may be associated with prolonged need for RRT or delayed kidney recovery.
The objective of this trial is to compare the effects of a high protein intake versus a standard protein intake on muscle mass change in critically ill patients with AKI requiring CRRT.
The goal of this clinical trial is to learn if high protein intake (1.5-1.7 g/kg/d) can reduce ICU associated weakness in critically ill patients with AKI requiring CRRT. The main questions it aims to answer is:
• Does High protein intake (1.5-1.7 g/kg/d) reduce the change in RF-CSA, as measured by ultrasonography at day 7 in critically ill patients with AKI requiring CRRT Researchers will compare drug high protein intake to standard protein intake to see if high protein intake effect on muscle mass by ultrasonography.
Participants will:
- Receive high protein group (1.5-1.7 g/kg/d) in High protein group and standard protein intake (1.0-1.2 g/kg/d) in control group for 7 days
- Rectus femoris ultrasonography was performed twice on day 1 and day 7
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Wiphat Kittiweerawong, MD
- 전화번호: +66899496165
- 이메일: inter.wiphat@gmail.com
연구 장소
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Bangkok
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Bangkok, Bangkok, 태국, 10330
- King chula memorial hospital
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연락하다:
- Nuttha Lumlertgul, MD, PhD
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연락하다:
- Wiphat Kittiweerawong, MD
- 전화번호: 0899496165
- 이메일: inter.wiphat@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adult (≥18 years old)
- AKI receiving CRRT within 7 days after ICU admission
- Achieve and tolerate calories 70% of target daily caloric requirement (20 kcal /kg/d) within 7 days after ICU admission by enteral feeding
- Participant or their surrogates is willing and able to give informed consent for participation in the study
Exclusion Criteria:
- Moribund or withholding of treatment
- Kidney transplant recipient
- Previously diagnosed end-stage kidney disease (ESKD) currently on kidney replacement therapy
- Pregnancy or breastfeeding
- Hepatic encephalopathy (West Haven grade 3-4)
- Burn patients
- Patients whom the responsible clinician felt that the patient either needed low or high protein
- Severe complications of diabetes such as ketoacidosis, hyperosmolar coma
- Had pre-existing neuromuscular disorders
- Previously leg amputations
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: High protein group
Patients will receive enteral nutrition via feeding tube.
The nutrition provided is a medical nutrition formula with a protein proportion of 7.5 g/100 kcal with caloric content 1.2 kcal/ml.
Deliverd protein 1.5-1.7 g/kg/d.
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Patients will receive enteral nutrition via feeding tube.
The nutrition provided is a medical nutrition formula with a protein proportion of 7.5 g/100 kcal with caloric content 1.2 kcal/ml.
|
|
활성 비교기: Standard protein group
Patients will receive enteral nutrition via feeding tube.
The nutrition provided is a medical nutrition formula with a protein proportion of 5 g/100 kcal with caloric content 1.2 kcal/ml.
Delivered protein 1.0-1.2
g/kg/d.
|
Patients will receive enteral nutrition via feeding tube.
The nutrition provided is a medical nutrition formula with a protein proportion of 5 g/100 kcal with caloric content 1.2 kcal/ml
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in RF-CSA ultrasonography
기간: At day 7 after randomization
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Change in RF-CSA, as measured by ultrasonography at day 7
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At day 7 after randomization
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Numbers of RRT-free days at day 28
기간: At day 28 after randomization
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At day 28 after randomization
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Numbers of MV-free days at day 28
기간: At day 28 after randomization
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At day 28 after randomization
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Change in muscle mass by BIA
기간: At day 7 after randomization
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measured by bioimpedance analysis at day 7
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At day 7 after randomization
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ICU length of stay
기간: At day 28 after randomization
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At day 28 after randomization
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Hospital length of stay
기간: At day 28 after randomization
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At day 28 after randomization
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Daily changes in urea levels
기간: From randomization to the end of treatment at 7 days
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From randomization to the end of treatment at 7 days
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Incidence of gastrointestinal intolerance
기간: through study completion, an average of 1 month
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through study completion, an average of 1 month
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CPAx
기간: At Randomization and At the end of treatment 7 days
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At Randomization and At the end of treatment 7 days
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 0306/69
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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