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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06452966
• Other study ID #: CMUH113-REC3-052
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2024
• Est. completion date: May 30, 2027

Study information

• Verified date: June 2024
• Source: China Medical University Hospital
• Contact: Yu-Chen Lee, M.D.,PhD
• Phone: 886-975-682023
• Email: 005167[@]tool.caaumed.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: May 30, 2027
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delayed Gastric Emptying
• Dyspepsia
• Gastroparesis
• Indigestion
• Morality
• Multiple Organ Failure
• Organ Failure, Multiple
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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.
• Routine ICU care
Patients will receive ICU care
• historical Routine ICU care
Patients had received ICU care

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".
Primary	hospital length of stay	The number of days a patient stays in the hospital	"through study completion, an average of 3 months".
Primary	Mechanical ventilation time	The number of days a patient requires mechanical ventilation	"through study completion, an average of 3 months".
Primary	Respiratory care center stay	The number of days a patient stays in the respiratory care center	"through study completion, an average of 3 months".
Primary	Patient survival and mortality	Measure ICU, RCC, and hospital mortality	"through study completion, an average of 1 year".
Secondary	Kidney function	Measured by blood urea nitrogen (BUN)	baseline, day 1-14 of the study
Secondary	Creatinine (creatinine)	Creatinine (creatinine) levels in blood sample	baseline, day 1-14 of the study
Secondary	Daily urine output	Daily urine output in ml	baseline, day 1-14 of the study
Secondary	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
Secondary	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
Secondary	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
Secondary	Oxygenation index	FiO2 rate in ventilator	baseline, day 1-14 of the study
Secondary	PaO2 rate	patients PaO2 rate in ventilator	baseline, day 1-14 of the study
Secondary	Respirator parameters	Tidal volume (VT) in ventilator	baseline, day 1-14 of the study
Secondary	Positive end-expiratory pressure (PEEP)	Positive end-expiratory pressure (PEEP) in ventilator	baseline, day 1-14 of the study
Secondary	Respiratory rate (RR)	Respiratory rate (RR) in ventilator	baseline, day 1-14 of the study
Secondary	Inspiratory airflow (V')	Inspiratory airflow (V') in ventilator	baseline, day 1-14 of the study
Secondary	Alanine transaminase (ALT)	Alanine transaminase (ALT) levels in blood sample	baseline, day 1-14 of the study
Secondary	Liver function	Aspartate transaminase (AST) levels in blood sample	baseline, day 1-14 of the study
Secondary	Alkaline phosphatase (ALP),	Alkaline phosphatase (ALP), levels in blood sample	baseline, day 1-14 of the study
Secondary	Albumin	Albumin levels in blood sample	baseline, day 1-14 of the study
Secondary	total protein	total protein levels in blood sample	baseline, day 1-14 of the study
Secondary	Bilirubin,	Bilirubin, levels in blood sample	baseline, day 1-14 of the study
Secondary	L-lactate dehydrogenase (LD)	L-lactate dehydrogenase (LD) levels in blood sample	baseline, day 1-14 of the study
Secondary	Prothrombin time (PT)	Prothrombin time (PT)	baseline, day 1-14 of the study
Secondary	Cardiovascular function	Measured by blood pressure	baseline, day 1-14 of the study
Secondary	use of vasopressors.	Measured by use of vasopressors.	baseline, day 1-14 of the study
Secondary	Glasgow Coma Scale (GCS)	Glasgow Coma Scale (GCS)	baseline, day 1-14 of the study