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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Experimental | patients in the group will recived one of or a combination of the following intervantions:
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. |
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| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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". |
| Measure | Description | Time Frame |
|---|---|---|
| Kidney function | Measured by blood urea nitrogen (BUN) | baseline, day 1-14 of the study |
| Creatinine (creatinine) | Creatinine (creatinine) levels in blood sample |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu-Chen Lee, M.D.,PhD | Contact | 886-975-682023 | 005167@tool.caaumed.org.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Recruiting | Taichung | 403 | Taiwan |
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a non-randomized real world data
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| Routine ICU care | Other | Patients will receive ICU care |
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| historical Routine ICU care | Other | Patients had received ICU care |
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| baseline, day 1-14 of the study |
| Daily urine output | Daily urine output in ml | 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. | 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. | 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. | baseline, day 1-14 of the study |
| Oxygenation index | FiO2 rate in ventilator | baseline, day 1-14 of the study |
| PaO2 rate | patients PaO2 rate in ventilator | baseline, day 1-14 of the study |
| Respirator parameters | Tidal volume (VT) in ventilator | baseline, day 1-14 of the study |
| Positive end-expiratory pressure (PEEP) | Positive end-expiratory pressure (PEEP) in ventilator | baseline, day 1-14 of the study |
| Respiratory rate (RR) | Respiratory rate (RR) in ventilator | baseline, day 1-14 of the study |
| Inspiratory airflow (V') | Inspiratory airflow (V') in ventilator | baseline, day 1-14 of the study |
| Alanine transaminase (ALT) | Alanine transaminase (ALT) levels in blood sample | baseline, day 1-14 of the study |
| Liver function | Aspartate transaminase (AST) levels in blood sample | baseline, day 1-14 of the study |
| Alkaline phosphatase (ALP), | Alkaline phosphatase (ALP), levels in blood sample | baseline, day 1-14 of the study |
| Albumin | Albumin levels in blood sample | baseline, day 1-14 of the study |
| total protein | total protein levels in blood sample | baseline, day 1-14 of the study |
| Bilirubin, | Bilirubin, levels in blood sample | baseline, day 1-14 of the study |
| L-lactate dehydrogenase (LD) | L-lactate dehydrogenase (LD) levels in blood sample | baseline, day 1-14 of the study |
| Prothrombin time (PT) | Prothrombin time (PT) | baseline, day 1-14 of the study |
| Cardiovascular function | Measured by blood pressure | baseline, day 1-14 of the study |
| use of vasopressors. | Measured by use of vasopressors. | baseline, day 1-14 of the study |
| Glasgow Coma Scale (GCS) | Glasgow Coma Scale (GCS) | baseline, day 1-14 of the study |
| ID | Term |
|---|---|
| D009102 | Multiple Organ Failure |
| D004415 | Dyspepsia |
| D018589 | Gastroparesis |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012769 | Shock |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D008516 | Medicine, Chinese Traditional |
| ID | Term |
|---|---|
| D008518 | Medicine, East Asian Traditional |
| D008519 | Medicine, Traditional |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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