Trauma Clinical Trial
Official title:
Plasma Cytochrome c as Biomarker of Traumatic Injury and Predictor of Outcome
Verified date | March 2018 |
Source | Advocate Health Care |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Cytochrome c is a mitochondrial protein that plays a key role in energy metabolism. When mitochondria are injured, cytochrome c may leave mitochondria and reach the bloodstream. The investigators plan to investigate whether circulating cytochrome c levels may serve as biomarker of traumatic injury correlating with (1) severity of traumatic injury, (2) development of organ dysfunction, and (3) clinical outcomes. The Trauma Services at ALGH will enroll over 8 months 100 consecutive trauma patients who require intubation for mechanical ventilation and survive to hospital admission. The Resuscitation Institute at RFUMS will measure cytochrome c levels in plasma taken upon hospital admission and subsequently at 24, 48, and 72 hours, with additional plasma stored for markers to be defined at a later time. Blood cytochrome c levels will be analyzed in relation to severity of traumatic injury, development of organ dysfunction, and clinical outcomes including survival and functional status (adjusted for covariates such as age, gender, type of trauma, time to stabilization, comorbidities, etc.) using information obtained as part of routine medical care. Successful completion of this project will support blood cytochrome c as biomarker of traumatic injury which could be used to identify severity, predict outcomes, and assess novel mitochondrial protective strategies.
Status | Completed |
Enrollment | 12 |
Est. completion date | March 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: Age 18 years or older. Blunt mechanism for the primary injury. Time from injury to hospital arrival is = 2 hours Mechanical ventilation for any reason, including surgery, within the initial 24 hours from hospital arrival. Any one of the following: - Systolic blood pressure <90 mmHg (Class III shock- >30 %blood loss) within 4 hours from hospital arrival. - Base deficit > 4 mmol/l in the first blood gas upon hospital arrival - Transfusion of = 2 units of packed red blood cells within =12 hours from hospital arrival. Exclusion Criteria (ANY SINGLE ONE): Known disease with life expectancy <6 months. Penetrating mechanism for the primary injury. Death within 4 hours from hospital arrival. |
Country | Name | City | State |
---|---|---|---|
United States | Advocate Lutheran General Hospital | Park Ridge | Illinois |
Lead Sponsor | Collaborator |
---|---|
Advocate Health Care | Rosalind Franklin University of Medicine and Science |
United States,
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* Note: There are 52 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma cytochrome c levels in relation to severity of traumatic injury | Relationship between plasma levels of cytochrome c and the initial severity of traumatic injury as assessed by the TRISS and the severity of initial presentation based on transfusion requirements and (if available) by blood gas and chemistry analysis along with lactic acid. | Day one. | |
Secondary | Plasma cytochrome c levels in relation to development of organ dysfunction and hospital outcomes | Relationship between plasma levels of cytochrome c and subsequent development of organ dysfunction assessed by daily measurements of MODS and SOFA and various clinical outcomes including length of stay in ICU and in the hospital, survival to hospital discharge, and functional status upon discharge. | From hospital admission until the date of discharge from the hospital, up to 26 weeks. | |
Secondary | Individual organ contribution to plasma cytochrome c levels | Contribution of individual organs injured to plasma cytochrome c levels (e.g., liver injury is likely to produce greater mitochondrial injury that thoracic injury given the greater mitochondrial density in liver tissue). | From hospital admission until the date of the last cytochrome c measurement (i.e., day three from hospital admission). |
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