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

Not Applicable

Recruiting

• Conditions: Indigestion; Morality; Organ Failure, Multiple; Delayed Gastric Emptying; Respiratory Failure
• Interventions: Other: Routine ICU care; Other: historical Routine ICU care; Other: traditional Chinese medicine

• Registration Number: NCT06452966
• Lead Sponsor: China Medical University Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2024-05-07
• Study First Submitted: 2024-05-20
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-06
• Last Update Submitted: 2024-06-06
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-11
• Primary Completion: 2026-12-30
• Study Completion: 2027-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Routine ICU care	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.
Historical control	historical Routine ICU care	Patients admitted to the same ICU in the period of 01.2019 to 12.2023. the patients did not recivied TCM intervantions
intervention group	traditional Chinese medicine	patients in the group will recived one of or a combination of the following intervantions: 1. 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. 2. 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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan