Clinical trial NCT06452966: The Impact and Effect of Traditional Chinese Medicine Treatment on Organ Failure in Critically Ill Patients
Official title: The Impact and Effect of Traditional Chinese Medicine Treatment on Organ Failure in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Organ Failure, Multiple
Indigestion
Delayed Gastric Emptying
Respiratory Failure
Morality
Keywords: acupuncture
chinese medicine
Organ Failure
intensive care
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 350
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a non-randomized real world data
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intensive care unit length of stay
timeFrame: "through study completion, an average of 3 months".
measure: hospital length of stay
timeFrame: "through study completion, an average of 3 months".
measure: Mechanical ventilation time
timeFrame: "through study completion, an average of 3 months".
measure: Respiratory care center stay
timeFrame: "through study completion, an average of 3 months".
measure: Patient survival and mortality
timeFrame: "through study completion, an average of 1 year".
Secondary outcomes:
measure: Kidney function
timeFrame: baseline, day 1-14 of the study
measure: Creatinine (creatinine)
timeFrame: baseline, day 1-14 of the study
measure: Daily urine output
timeFrame: baseline, day 1-14 of the study
measure: Number of days out of the first 14 days the patients reach 70% of their target energy expenditure.
timeFrame: baseline, day 1-14 of the study
measure: Number of days to reach 80% of target energy expenditure.
timeFrame: baseline, day 1-14 of the study
measure: Number of days to reach 100% of target energy expenditure.
timeFrame: baseline, day 1-14 of the study
measure: Oxygenation index
timeFrame: baseline, day 1-14 of the study
measure: PaO2 rate
timeFrame: baseline, day 1-14 of the study
measure: Respirator parameters
timeFrame: baseline, day 1-14 of the study
measure: Positive end-expiratory pressure (PEEP)
timeFrame: baseline, day 1-14 of the study
measure: Respiratory rate (RR)
timeFrame: baseline, day 1-14 of the study
measure: Inspiratory airflow (V')
timeFrame: baseline, day 1-14 of the study
measure: Alanine transaminase (ALT)
timeFrame: baseline, day 1-14 of the study
measure: Liver function
timeFrame: baseline, day 1-14 of the study
measure: Alkaline phosphatase (ALP),
timeFrame: baseline, day 1-14 of the study
measure: Albumin
timeFrame: baseline, day 1-14 of the study
measure: total protein
timeFrame: baseline, day 1-14 of the study
measure: Bilirubin,
timeFrame: baseline, day 1-14 of the study
measure: L-lactate dehydrogenase (LD)
timeFrame: baseline, day 1-14 of the study
measure: Prothrombin time (PT)
timeFrame: baseline, day 1-14 of the study
measure: Cardiovascular function
timeFrame: baseline, day 1-14 of the study
measure: use of vasopressors.
timeFrame: baseline, day 1-14 of the study
measure: Glasgow Coma Scale (GCS)
timeFrame: baseline, day 1-14 of the study
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: