Major Trauma Clinical Trial
Official title:
The Effects of Electroacupuncture and Laser Acupuncture Therapy for Patients With Major Trauma
NCT number | NCT04970433 |
Other study ID # | NMRPG8L6041 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 12, 2021 |
Est. completion date | July 2024 |
Major trauma is a significant cause for morbidity and mortality in the world. After traumatic injury, the damage tissue could induce systemic inflammatory response (SIRS) and activate autonomic nervous system in response to stress, followed by compensatory anti-inflammatory response (CARS). Imbalance of SIRS and CARS may lead to organ failures, sepsis and death.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | July 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - Male or female aged 20 years or older - Confirmed diagnosis of major trauma with ISS = 16 Exclusion Criteria: - Pregnancy - Malignancy - Pacemaker - Status epilepticus - Severe medical disease - Life threatening - Prior history of drug or alcohol dependence - Immunodeficiency - Vagotomy |
Country | Name | City | State |
---|---|---|---|
Taiwan | Kaohsiung Chang Gung Memorial Hospital | Kaohsiung |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Length of hospital stay | Count the total days of hospitalization | up to 24 weeks | |
Secondary | CRP | Inflammatory mediator, CRP | measured at 48 hours, 7 days and 14 days | |
Secondary | IL-6 | Inflammatory mediator, IL-6 | measured at 48 hours, 7 days and 14 days | |
Secondary | TNF-a | Inflammatory mediator, TNF-a | measured at 48 hours, 7 days and 14 days | |
Secondary | IL-1ß | Inflammatory mediator, IL-1ß | measured at 48 hours, 7 days and 14 days | |
Secondary | IL-10 | Inflammatory mediator, IL-10 | measured at 48 hours, 7 days and 14 days | |
Secondary | Sequential organ failure assessment (SOFA) score | The SOFA score is a simple and objective score that allows for calculation of both the number and the severity of organ dysfunction in six organ systems (respiratory, coagulatory, liver, cardiovascular, renal, and neurologic), and the score can measure individual or aggregate organ dysfunction.The SOFA score ranges from 0 to 24; higher scores mean a worse outcome. | measured at 48 hours, 7 days and 14 days | |
Secondary | WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) 12-item version | WHODAS 2.0 is used to measure of disability after major trauma. | measured at 3 and 6 months | |
Secondary | Peripheral Blood Mononuclear Cell (PBMC) analysis | PBMC analysis by flow cytometry | measured at 48 hours, 7 days and 14 days |
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