An interventional study of traditional Chinese medicine and Routine ICU care in Organ Failure, Multiple, Indigestion and Delayed Gastric Emptying, sponsored by China Medical University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-06-11.
Sponsored by China Medical University Hospital · Not applicable, Interventional, and Treatment
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.
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.
193 studies on the registry are indexed under Multiple Organ Failure; 47 are open to participants now.
This study's planned enrollment of 350 is above the median of 88 across 90 interventional studies indexed under Multiple Organ Failure.
Browse Multiple Organ Failure studies →China Medical University Hospital is the lead sponsor of 479 studies on the registry; 115 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
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.
Other: traditional Chinese medicine
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 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 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.
Also known as: Oral Chinese medicine decoction and/or Acupuncture or low level laser acupuncture
Patients will receive ICU care
Also known as: ICU care
Patients had received ICU care
Also known as: Routine ICU care
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".
hospital length of stay
The number of days a patient stays in the hospital
Time frame: "through study completion, an average of 3 months".
Mechanical ventilation time
The number of days a patient requires mechanical ventilation
Time frame: "through study completion, an average of 3 months".
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".
Patient survival and mortality
Measure ICU, RCC, and hospital mortality
Time frame: "through study completion, an average of 1 year".
Kidney function
Measured by blood urea nitrogen (BUN)
Time frame: baseline, day 1-14 of the study
Creatinine (creatinine)
Creatinine (creatinine) levels in blood sample
Time frame: baseline, day 1-14 of the study
Daily urine output
Daily urine output in ml
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline, day 1-14 of the study
Oxygenation index
FiO2 rate in ventilator
Time frame: baseline, day 1-14 of the study
PaO2 rate
patients PaO2 rate in ventilator
Time frame: baseline, day 1-14 of the study
Respirator parameters
Tidal volume (VT) in ventilator
Time frame: baseline, day 1-14 of the study
Positive end-expiratory pressure (PEEP)
Positive end-expiratory pressure (PEEP) in ventilator
Time frame: baseline, day 1-14 of the study
Respiratory rate (RR)
Respiratory rate (RR) in ventilator
Time frame: baseline, day 1-14 of the study
Inspiratory airflow (V')
Inspiratory airflow (V') in ventilator
Time frame: baseline, day 1-14 of the study
Alanine transaminase (ALT)
Alanine transaminase (ALT) levels in blood sample
Time frame: baseline, day 1-14 of the study
Liver function
Aspartate transaminase (AST) levels in blood sample
Time frame: baseline, day 1-14 of the study
Alkaline phosphatase (ALP),
Alkaline phosphatase (ALP), levels in blood sample
Time frame: baseline, day 1-14 of the study
Albumin
Albumin levels in blood sample
Time frame: baseline, day 1-14 of the study
total protein
total protein levels in blood sample
Time frame: baseline, day 1-14 of the study
Bilirubin,
Bilirubin, levels in blood sample
Time frame: baseline, day 1-14 of the study
L-lactate dehydrogenase (LD)
L-lactate dehydrogenase (LD) levels in blood sample
Time frame: baseline, day 1-14 of the study
Prothrombin time (PT)
Prothrombin time (PT)
Time frame: baseline, day 1-14 of the study
Cardiovascular function
Measured by blood pressure
Time frame: baseline, day 1-14 of the study
use of vasopressors.
Measured by use of vasopressors.
Time frame: baseline, day 1-14 of the study
Glasgow Coma Scale (GCS)
Glasgow Coma Scale (GCS)
Time frame: baseline, day 1-14 of the study
Started May 2024 (actual). Primary completion is estimated for Dec 2026, 31 months after the start.
Of 28 interventional studies with no phase under Multiple Organ Failure, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 54. This study's planned 31 months is above that.
How these figures are worked out, and which studies are left out of them.
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