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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06452966
Other study ID # CMUH113-REC3-052
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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