Delayed Gastric Emptying, Indigestion, Morality, Organ Failure, Multiple, Respiratory Failure
Conditions
Keywords
acupuncture, chinese medicine, Organ Failure, intensive care
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.
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
OTHERtraditional 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 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.
OTHERRoutine ICU care
Patients will receive ICU care
OTHERhistorical Routine ICU care
Patients had received ICU care
Sponsors
China Medical University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
a non-randomized real world data
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensive care unit length of stay | through study completion, an average of 3 months. | the number of days a patient stays in the Intensive care unit |
| hospital length of stay | through study completion, an average of 3 months. | The number of days a patient stays in the hospital |
| Mechanical ventilation time | through study completion, an average of 3 months. | The number of days a patient requires mechanical ventilation |
| Respiratory care center stay | through study completion, an average of 3 months. | The number of days a patient stays in the respiratory care center |
| Patient survival and mortality | through study completion, an average of 1 year. | Measure ICU, RCC, and hospital mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of days to reach 100% of target energy expenditure. | 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. |
| Oxygenation index | baseline, day 1-14 of the study | FiO2 rate in ventilator |
| PaO2 rate | baseline, day 1-14 of the study | patients PaO2 rate in ventilator |
| Respirator parameters | baseline, day 1-14 of the study | Tidal volume (VT) in ventilator |
| Positive end-expiratory pressure (PEEP) | baseline, day 1-14 of the study | Positive end-expiratory pressure (PEEP) in ventilator |
| Respiratory rate (RR) | baseline, day 1-14 of the study | Respiratory rate (RR) in ventilator |
| Inspiratory airflow (V') | baseline, day 1-14 of the study | Inspiratory airflow (V') in ventilator |
| Alanine transaminase (ALT) | baseline, day 1-14 of the study | Alanine transaminase (ALT) levels in blood sample |
| Liver function | baseline, day 1-14 of the study | Aspartate transaminase (AST) levels in blood sample |
| Kidney function | baseline, day 1-14 of the study | Measured by blood urea nitrogen (BUN) |
| Albumin | baseline, day 1-14 of the study | Albumin levels in blood sample |
| total protein | baseline, day 1-14 of the study | total protein levels in blood sample |
| Bilirubin, | baseline, day 1-14 of the study | Bilirubin, levels in blood sample |
| L-lactate dehydrogenase (LD) | baseline, day 1-14 of the study | L-lactate dehydrogenase (LD) levels in blood sample |
| Prothrombin time (PT) | baseline, day 1-14 of the study | Prothrombin time (PT) |
| Cardiovascular function | baseline, day 1-14 of the study | Measured by blood pressure |
| use of vasopressors. | baseline, day 1-14 of the study | Measured by use of vasopressors. |
| Glasgow Coma Scale (GCS) | baseline, day 1-14 of the study | Glasgow Coma Scale (GCS) |
| Alkaline phosphatase (ALP), | baseline, day 1-14 of the study | Alkaline phosphatase (ALP), levels in blood sample |
| Creatinine (creatinine) | baseline, day 1-14 of the study | Creatinine (creatinine) levels in blood sample |
| Daily urine output | baseline, day 1-14 of the study | Daily urine output in ml |
| 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 | Daily intake Number of days out of the first 14 days the patients reach 70% of their target energy expenditure. |
| Number of days to reach 80% of target energy expenditure. | 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. |
Countries
Taiwan
Contacts
Primary ContactYu-Chen Lee, M.D.,PhD
Outcome results
None listed