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NCT Number: NCT06452966

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

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.

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Key information

Conditions

Organ Failure, Multiple Delayed Gastric Emptying Digestive System Diseases Dyspepsia Gastrointestinal Diseases Gastroparesis Indigestion Morality Multiple Organ Failure Neurologic Manifestations Paralysis Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Shock Signs and Symptoms Signs and Symptoms, Digestive Stomach Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University Hospital

Taichung, 403, Taiwan

Location status: Recruiting

Location contact

Yu-Chen Lee, PHD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

traditional Chinese medicine

Other

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.

Other names: Oral Chinese medicine decoction and/or Acupuncture or low level laser acupuncture

Routine ICU care

Other

Patients will receive ICU care

Other names: ICU care

historical Routine ICU care

Other

Patients had received ICU care

Other names: Routine ICU care

Primary outcomes

  1. Intensive care unit length of stay

    Time frame: "through study completion, an average of 3 months".

    the number of days a patient stays in the Intensive care unit

  2. hospital length of stay

    Time frame: "through study completion, an average of 3 months".

    The number of days a patient stays in the hospital

  3. Mechanical ventilation time

    Time frame: "through study completion, an average of 3 months".

    The number of days a patient requires mechanical ventilation

  4. Respiratory care center stay

    Time frame: "through study completion, an average of 3 months".

    The number of days a patient stays in the respiratory care center

  5. Patient survival and mortality

    Time frame: "through study completion, an average of 1 year".

    Measure ICU, RCC, and hospital mortality

Secondary outcomes

  1. Kidney function

    Time frame: baseline, day 1-14 of the study

    Measured by blood urea nitrogen (BUN)

  2. Creatinine (creatinine)

    Time frame: baseline, day 1-14 of the study

    Creatinine (creatinine) levels in blood sample

  3. Daily urine output

    Time frame: baseline, day 1-14 of the study

    Daily urine output in ml

  4. 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

    Daily intake Number of days out of the first 14 days the patients reach 70% of their target energy expenditure.

  5. Number of days to reach 80% of target energy expenditure.

    Time frame: baseline, day 1-14 of the study

    Daily intake, number of days out of the first 14 days the patients reach 80% of target energy expenditure.

  6. Number of days to reach 100% of target energy expenditure.

    Time frame: baseline, day 1-14 of the study

    Daily intake Number of days out of the first 14 days the patients reach100% of target energy expenditure.

  7. Oxygenation index

    Time frame: baseline, day 1-14 of the study

    FiO2 rate in ventilator

  8. PaO2 rate

    Time frame: baseline, day 1-14 of the study

    patients PaO2 rate in ventilator

  9. Respirator parameters

    Time frame: baseline, day 1-14 of the study

    Tidal volume (VT) in ventilator

  10. Positive end-expiratory pressure (PEEP)

    Time frame: baseline, day 1-14 of the study

    Positive end-expiratory pressure (PEEP) in ventilator

  11. Respiratory rate (RR)

    Time frame: baseline, day 1-14 of the study

    Respiratory rate (RR) in ventilator

  12. Inspiratory airflow (V')

    Time frame: baseline, day 1-14 of the study

    Inspiratory airflow (V') in ventilator

  13. Alanine transaminase (ALT)

    Time frame: baseline, day 1-14 of the study

    Alanine transaminase (ALT) levels in blood sample

  14. Liver function

    Time frame: baseline, day 1-14 of the study

    Aspartate transaminase (AST) levels in blood sample

  15. Alkaline phosphatase (ALP),

    Time frame: baseline, day 1-14 of the study

    Alkaline phosphatase (ALP), levels in blood sample

  16. Albumin

    Time frame: baseline, day 1-14 of the study

    Albumin levels in blood sample

  17. total protein

    Time frame: baseline, day 1-14 of the study

    total protein levels in blood sample

  18. Bilirubin,

    Time frame: baseline, day 1-14 of the study

    Bilirubin, levels in blood sample

  19. L-lactate dehydrogenase (LD)

    Time frame: baseline, day 1-14 of the study

    L-lactate dehydrogenase (LD) levels in blood sample

  20. Prothrombin time (PT)

    Time frame: baseline, day 1-14 of the study

    Prothrombin time (PT)

  21. Cardiovascular function

    Time frame: baseline, day 1-14 of the study

    Measured by blood pressure

  22. use of vasopressors.

    Time frame: baseline, day 1-14 of the study

    Measured by use of vasopressors.

  23. Glasgow Coma Scale (GCS)

    Time frame: baseline, day 1-14 of the study

    Glasgow Coma Scale (GCS)

Study contacts

Contact information is provided by the study sponsor or research team.

Yu-Chen Lee, M.D.,PhD

CONTACT

[email protected]

886-975-682023

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 11, 2024
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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