The Impact and Effect of Traditional Chinese Medicine Treatment on Organ Failure in Critically Ill Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorChina Medical University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients' family members refuse TCM intervention
Trial design
Design model
Parallel
Treatments tested in this trial
traditional Chinese medicine
Other interventionpatients 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
Other interventionPatients will receive ICU care
historical Routine ICU care
Other interventionPatients had received ICU care
Treatment groups
350 Participants
are divided into 3 treatment groupsGroup A: intervention groupExperimental treatment 1 intervention
Group B: control groupActive comparator 1 intervention
Group C: Historical controlOther 1 intervention
Trial outcomes
Primary outcomes
1
Intensive care unit length of stay
the number of days a patient stays in the Intensive care unit
Time frame
"through study completion, an average of 3 months".2
hospital length of stay
The number of days a patient stays in the hospital
Time frame
"through study completion, an average of 3 months".3
Mechanical ventilation time
The number of days a patient requires mechanical ventilation
Time frame
"through study completion, an average of 3 months".4
Respiratory care center stay
The number of days a patient stays in the respiratory care center
Time frame
"through study completion, an average of 3 months".Secondary outcomes
1
Kidney function
Measured by blood urea nitrogen (BUN)
Time frame
baseline, day 1-14 of the study2
Creatinine (creatinine)
Creatinine (creatinine) levels in blood sample
Time frame
baseline, day 1-14 of the study3
Daily urine output
Daily urine output in ml
Time frame
baseline, day 1-14 of the study4
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.
Time frame
baseline, day 1-14 of the studySponsors and contacts
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Source ClinicalTrials.gov