The Impact and Effect of Traditional Chinese Medicine Treatment on Organ Failure in Critically Ill Patients

Critically ill patients are at risk of or suffering from one or more key organs or organ system failure. This study will measure the effect of traditional Chinese medicine(TCM) interventions on critically ill patients admitted to the intensive care unit (ICU).

The goal of this clinical trial is to learn if traditional Chinese medicine(TCM) is effective for prevention and treatment of organ failure in ICU patients. Patients in this group will receive intervention for 2 weeks.

A multi-center non-randomized real word data study, will include 3 groups: intervention group (TCM)(n=70), control group and historical control group (admitted to the same ICU in the period of 01.2019 to 12.2023).

Main outcomes include sequential organ failure assessment (SOFA) score, ICU length of stay, hospital length of stay, number of days of respirator uses and western medicine medication used study follow up will be 2 weeks.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Failure; Morality; Delayed Gastric Emptying; Organ Failure, Multiple; Indigestion
• Intervention / Treatment: Other: traditional Chinese medicine; Other: Routine ICU care; Other: historical Routine ICU care

Detailed Description

Critically ill patients are at risk of or suffering from one or more key organs or organ system failure. This study will measure the effect of traditional Chinese medicine(TCM) interventions on critically ill patients admitted to the intensive care unit (ICU).

A multi center non-randomized real word data study, will include 3 groups: intervention group (n=70), control group (patients recruited enrolled to the ICU during the study period) and historical control group (admitted to the same ICU in the period of 01.2019 to 12.2023). The intervention group will receive traditional Chinese herbal medicine and/or acupuncture and/or low level laser applied on acupuncture points depending on TCM doctor decision and patient TCM diagnosis. Intervention period will be 2 weeks.

Main outcomes include sequential organ failure assessment (SOFA) score, ICU length of stay, hospital length of stay, number of days of respirator uses and western medicine medication used study follow up will be 2 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu-Chen Lee, M.D.,PhD; Phone Number: 886-975-682023; Email: 005167@tool.caaumed.org.tw

Study Locations

• Taiwan
  • Taichung, Taiwan, 403
    • Recruiting
    • China Medical University Hospital
    • Contact: Yu-Chen Lee, PHD; Email: 005167@tool.caaumed.org.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 20 and above
• Surgical ICU patients
• The use of Chinese medicine must be approved by the attending physician in the surgical intensive care unit

Exclusion criteria:

• Patients' family members refuse TCM intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; patients in the group will recived one of or a combination of the following intervantions: Oral Chinese medicine decoction:The Chinese medicine practitioner will personally examine the patient and judge the patient's condition through the four diagnostic methods of traditional Chinese medicine(TCM): sight, smell, inquiry, and incision. Based on the syndrome differentiation and treatment of the patient's condition, he or she will prescribe an oral Chinese herbal decoction, two to three times a day, for two weeks.; Acupuncture or low level laser acupuncture treatment: Chinese medicine practitioners select acupuncture points for treatment based on the patient's condition and treat them twice a week for 20 minutes each time for a total of two weeks. the intervantion depents on the TCM doctor decision based on the patient's diagnosis and needs. in addition, the patients will recive ICU care and medication based on patient's needs.	Other: traditional Chinese medicine; patients in the group will receive one of or a combination of the following interventions: Oral Chinese medicine decoction: The Chinese medicine practitioner will personally examine the patient and judge the patient's condition through the four diagnostic methods of traditional Chinese medicine(TCM): sight, smell, inquiry, and incision. Based on the syndrome differentiation and treatment of the patient's condition, he or she will prescribe an oral Chinese herbal decoction, two to three times a day, for two weeks. Acupuncture or low level laser acupuncture treatment: Chinese medicine practitioners select acupuncture points for treatment based on the patient's condition and treat them twice a week for 20 minutes each time for a total of two weeks. the intervantion depents on the TCM doctor decision based on the patient's diagnosis and needs. in addition, the patients will recive ICU care and medication based on patient's needs.; Other Names: Oral Chinese medicine decoction and/or Acupuncture or low level laser acupuncture
Active Comparator: control group; the patients in this group will receive routine ICU care. the patients will be recruted during the study period. the patients will not recive TCM intervantions.	Other: Routine ICU care; Patients will receive ICU care; Other Names: ICU care
Other: Historical control; Patients admitted to the same ICU in the period of 01.2019 to 12.2023. the patients did not recivied TCM intervantions	Other: historical Routine ICU care; Patients had received ICU care; Other Names: Routine ICU care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensive care unit length of stay	the number of days a patient stays in the Intensive care unit	"through study completion, an average of 3 months".
hospital length of stay	The number of days a patient stays in the hospital	"through study completion, an average of 3 months".
Mechanical ventilation time	The number of days a patient requires mechanical ventilation	"through study completion, an average of 3 months".
Respiratory care center stay	The number of days a patient stays in the respiratory care center	"through study completion, an average of 3 months".
Patient survival and mortality	Measure ICU, RCC, and hospital mortality	"through study completion, an average of 1 year".

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kidney function	Measured by blood urea nitrogen (BUN)	baseline, day 1-14 of the study
Creatinine (creatinine)	Creatinine (creatinine) levels in blood sample	baseline, day 1-14 of the study
Daily urine output	Daily urine output in ml	baseline, day 1-14 of the study
Number of days out of the first 14 days the patients reach 70% of their target energy expenditure.	Daily intake Number of days out of the first 14 days the patients reach 70% of their target energy expenditure.	baseline, day 1-14 of the study
Number of days to reach 80% of target energy expenditure.	Daily intake, number of days out of the first 14 days the patients reach 80% of target energy expenditure.	baseline, day 1-14 of the study
Number of days to reach 100% of target energy expenditure.	Daily intake Number of days out of the first 14 days the patients reach100% of target energy expenditure.	baseline, day 1-14 of the study
Oxygenation index	FiO2 rate in ventilator	baseline, day 1-14 of the study
PaO2 rate	patients PaO2 rate in ventilator	baseline, day 1-14 of the study
Respirator parameters	Tidal volume (VT) in ventilator	baseline, day 1-14 of the study
Positive end-expiratory pressure (PEEP)	Positive end-expiratory pressure (PEEP) in ventilator	baseline, day 1-14 of the study
Respiratory rate (RR)	Respiratory rate (RR) in ventilator	baseline, day 1-14 of the study
Inspiratory airflow (V')	Inspiratory airflow (V') in ventilator	baseline, day 1-14 of the study
Alanine transaminase (ALT)	Alanine transaminase (ALT) levels in blood sample	baseline, day 1-14 of the study
Liver function	Aspartate transaminase (AST) levels in blood sample	baseline, day 1-14 of the study
Alkaline phosphatase (ALP),	Alkaline phosphatase (ALP), levels in blood sample	baseline, day 1-14 of the study
Albumin	Albumin levels in blood sample	baseline, day 1-14 of the study
total protein	total protein levels in blood sample	baseline, day 1-14 of the study
Bilirubin,	Bilirubin, levels in blood sample	baseline, day 1-14 of the study
L-lactate dehydrogenase (LD)	L-lactate dehydrogenase (LD) levels in blood sample	baseline, day 1-14 of the study
Prothrombin time (PT)	Prothrombin time (PT)	baseline, day 1-14 of the study
Cardiovascular function	Measured by blood pressure	baseline, day 1-14 of the study
use of vasopressors.	Measured by use of vasopressors.	baseline, day 1-14 of the study
Glasgow Coma Scale (GCS)	Glasgow Coma Scale (GCS)	baseline, day 1-14 of the study

Collaborators and Investigators

• Sponsor: China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: acupuncture; intensive care; Organ Failure; chinese medicine
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Stomach Diseases; Shock; Paralysis; Dyspepsia; Respiratory Insufficiency; Gastroparesis; Multiple Organ Failure
• Other Study ID Numbers: CMUH113-REC3-052

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No