Organ Failure, MultipleNCT06452966
The Impact and Effect of Traditional Chinese Medicine Treatment on Organ Failure in Critically Ill Patients
A study testing traditional Chinese medicine, Routine ICU care and historical Routine ICU care in people with Organ Failure, Multiple and Indigestion, run by China Medical University Hospital at 1 site in Taiwan.
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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Organ Failure, Multiple, Indigestion, Delayed Gastric Emptying
- What is being tested?
- traditional Chinese medicine, Routine ICU care and historical Routine ICU care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 May 2024to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients' family members refuse TCM intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 403
Yu-Chen Lee, PHD, 005167@tool.caaumed.org.tw
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).
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.
Read more
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.
Read the 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.
- Conditions
- Organ Failure, Multiple, Indigestion, Delayed Gastric Emptying, Respiratory Failure, Morality
- Being tested
- traditional Chinese medicine, Routine ICU care, historical Routine ICU care
- Keywords
- acupuncture, chinese medicine, Organ Failure, intensive care
- Medical subject headings
- Multiple Organ Failure, Dyspepsia, Gastroparesis, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional Chinese medicineOther
Also called Oral Chinese medicine decoction and/or Acupuncture or low level laser acupuncture
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 careOther
Also called ICU care
Patients will receive ICU care
historical Routine ICU careOther
Also called Routine ICU care
Patients had received ICU care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: Other: historical Routine ICU care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensive care unit length of stay
the number of days a patient stays in the Intensive care unit
Measured: "through study completion, an average of 3 months".
hospital length of stay
The number of days a patient stays in the hospital
Measured: "through study completion, an average of 3 months".
Mechanical ventilation time
The number of days a patient requires mechanical ventilation
Measured: "through study completion, an average of 3 months".
Respiratory care center stay
The number of days a patient stays in the respiratory care center
Measured: "through study completion, an average of 3 months".
Patient survival and mortality
Measure ICU, RCC, and hospital mortality
Measured: "through study completion, an average of 1 year".
Secondary outcomes (23)
Kidney function
Measured by blood urea nitrogen (BUN)
Measured: baseline, day 1-14 of the study
Creatinine (creatinine)
Creatinine (creatinine) levels in blood sample
Measured: baseline, day 1-14 of the study
Daily urine output
Daily urine output in ml
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, day 1-14 of the study
Oxygenation index
FiO2 rate in ventilator
Measured: baseline, day 1-14 of the study
PaO2 rate
patients PaO2 rate in ventilator
Measured: baseline, day 1-14 of the study
Respirator parameters
Tidal volume (VT) in ventilator
Measured: baseline, day 1-14 of the study
Positive end-expiratory pressure (PEEP)
Positive end-expiratory pressure (PEEP) in ventilator
Measured: baseline, day 1-14 of the study
Respiratory rate (RR)
Respiratory rate (RR) in ventilator
Measured: baseline, day 1-14 of the study
Inspiratory airflow (V')
Inspiratory airflow (V') in ventilator
Measured: baseline, day 1-14 of the study
Alanine transaminase (ALT)
Alanine transaminase (ALT) levels in blood sample
Measured: baseline, day 1-14 of the study
Liver function
Aspartate transaminase (AST) levels in blood sample
Measured: baseline, day 1-14 of the study
Alkaline phosphatase (ALP),
Alkaline phosphatase (ALP), levels in blood sample
Measured: baseline, day 1-14 of the study
Albumin
Albumin levels in blood sample
Measured: baseline, day 1-14 of the study
total protein
total protein levels in blood sample
Measured: baseline, day 1-14 of the study
Bilirubin,
Bilirubin, levels in blood sample
Measured: baseline, day 1-14 of the study
L-lactate dehydrogenase (LD)
L-lactate dehydrogenase (LD) levels in blood sample
Measured: baseline, day 1-14 of the study
Prothrombin time (PT)
Prothrombin time (PT)
Measured: baseline, day 1-14 of the study
Cardiovascular function
Measured by blood pressure
Measured: baseline, day 1-14 of the study
use of vasopressors.
Measured by use of vasopressors.
Measured: baseline, day 1-14 of the study
Glasgow Coma Scale (GCS)
Glasgow Coma Scale (GCS)
Measured: baseline, day 1-14 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start7 May 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ Failure, MultipleStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- a non-randomized real world data
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452966
- Sponsor's protocol ID
- CMUH113-REC3-052
- Status last verified
- Jun 2024
- First submitted
- 20 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact and Effect of Traditional Chinese Medicine Treatment on Organ Failure in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06452966
- Acronym / sponsor ID
- CMUH113-REC3-052
- Conditions
- Organ Failure, Multiple, Indigestion, Delayed Gastric Emptying, Respiratory Failure, Morality
- Keywords
- acupuncture, chinese medicine, Organ Failure, intensive care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- a non-randomized real world data
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: traditional Chinese medicinepatients 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. |
| control group | Active comparator | Other: Routine ICU carethe 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. |
| Historical control | Other | Other: historical Routine ICU carePatients admitted to the same ICU in the period of 01.2019 to 12.2023. the patients did not recivied TCM intervantions |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients' family members refuse TCM intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| traditional Chinese medicineAlso: Oral Chinese medicine decoction and/or Acupuncture or low level laser acupuncturepatients 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 | intervention group |
| Routine ICU careAlso: ICU carePatients will receive ICU care | Other | control group |
| historical Routine ICU careAlso: Routine ICU carePatients had received ICU care | Other | Historical control |
Primary outcome
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
hospital length of stay
Time frame: "through study completion, an average of 3 months".
The number of days a patient stays in the hospital
Mechanical ventilation time
Time frame: "through study completion, an average of 3 months".
The number of days a patient requires mechanical ventilation
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
Patient survival and mortality
Time frame: "through study completion, an average of 1 year".
Measure ICU, RCC, and hospital mortality
23 secondary outcomes
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
Alanine transaminase (ALT)
Time frame: baseline, day 1-14 of the study
Liver function
Time frame: baseline, day 1-14 of the study
Alkaline phosphatase (ALP),
Time frame: baseline, day 1-14 of the study
Albumin
Time frame: baseline, day 1-14 of the study
total protein
Time frame: baseline, day 1-14 of the study
Bilirubin,
Time frame: baseline, day 1-14 of the study
L-lactate dehydrogenase (LD)
Time frame: baseline, day 1-14 of the study
Prothrombin time (PT)
Time frame: baseline, day 1-14 of the study
Cardiovascular function
Time frame: baseline, day 1-14 of the study
use of vasopressors.
Time frame: baseline, day 1-14 of the study
Glasgow Coma Scale (GCS)
Time frame: baseline, day 1-14 of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional Chinese medicine, Routine ICU care and historical Routine ICU care in people with Organ Failure, Multiple and Indigestion, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu-Chen Lee, M.D.,PhD (886-975-682023, 005167@tool.caaumed.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensive care unit length of stay (time frame: "through study completion, an average of 3 months".). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.