NCT06452966

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
May 2024May 2027

Study Start

First participant enrolled

May 7, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2027

Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

2.6 years

First QC Date

May 20, 2024

Last Update Submit

June 6, 2024

Conditions

Organ Failure, MultipleIndigestionDelayed Gastric EmptyingRespiratory FailureMorality

Keywords

acupuncturechinese medicineOrgan Failureintensive care

Outcome Measures

Primary Outcomes (5)

  • 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".

  • hospital length of stay

    The number of days a patient stays in the hospital

    "through study completion, an average of 3 months".

  • Mechanical ventilation time

    The number of days a patient requires mechanical ventilation

    "through study completion, an average of 3 months".

  • Respiratory care center stay

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

    "through study completion, an average of 3 months".

  • Patient survival and mortality

    Measure ICU, RCC, and hospital mortality

    "through study completion, an average of 1 year".

Secondary Outcomes (23)

  • Kidney function

    baseline, day 1-14 of the study

  • Creatinine (creatinine)

    baseline, day 1-14 of the study

  • Daily urine output

    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.

    baseline, day 1-14 of the study

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

    baseline, day 1-14 of the study

  • +18 more secondary outcomes

Study Arms (3)

intervention group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

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

Historical control

OTHER

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

Interventions

traditional Chinese medicineOTHER

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
intervention group
Routine ICU careOTHER

Patients will receive ICU care

Also known as: ICU care
control group
historical Routine ICU careOTHER

Patients had received ICU care

Also known as: Routine ICU care
Historical control

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients' family members refuse TCM intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 403, Taiwan

RECRUITING

MeSH Terms

Conditions

Multiple Organ FailureDyspepsiaGastroparesisRespiratory Insufficiency

Interventions

Medicine, Chinese Traditional

Condition Hierarchy (Ancestors)

ShockPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and SymptomsStomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsRespiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Medicine, East Asian TraditionalMedicine, TraditionalComplementary TherapiesTherapeutics

Central Study Contacts

Yu-Chen Lee, M.D.,PhD

CONTACT

886-975-682023005167@tool.caaumed.org.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: a non-randomized real world data
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2024

First Posted

June 11, 2024

Study Start

May 7, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

May 30, 2027

Last Updated

June 11, 2024

Record last verified: 2024-06

Locations

TW(1)