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Recruiting NCT06452966

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

No phase Interventional Organ Failure, Multiple Indigestion Delayed Gastric Emptying Respiratory Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: traditional Chinese medicine, Routine ICU care, historical Routine ICU care.
Who it may be relevant to
Registry conditions: Organ Failure, Multiple, Indigestion, Delayed Gastric Emptying, Respiratory Failure. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Intensive care unit length of stay [Time frame: "through study completion, an average of 3 months".]
  • hospital length of stay [Time frame: "through study completion, an average of 3 months".]
  • Mechanical ventilation time [Time frame: "through study completion, an average of 3 months".]
  • Respiratory care center stay [Time frame: "through study completion, an average of 3 months".]
  • Patient survival and mortality [Time frame: "through study completion, an average of 1 year".]
Secondary outcome measures (12)
  • Kidney function [Time frame: baseline, day 1-14 of the study]
  • Creatinine (creatinine) [Time frame: baseline, day 1-14 of the study]
  • Daily urine output [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. [Time frame: baseline, day 1-14 of the study]
  • Number of days to 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. [Time frame: baseline, day 1-14 of the study]
  • Oxygenation index [Time frame: baseline, day 1-14 of the study]
  • PaO2 rate [Time frame: baseline, day 1-14 of the study]
  • Respirator parameters [Time frame: baseline, day 1-14 of the study]
  • Positive end-expiratory pressure (PEEP) [Time frame: baseline, day 1-14 of the study]
  • Respiratory rate (RR) [Time frame: baseline, day 1-14 of the study]
  • Inspiratory airflow (V') [Time frame: baseline, day 1-14 of the study]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • China Medical University Hospital — Taichung

Identifiers

NCT: NCT06452966 · CMUH113-REC3-052

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗