- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04100369
Admission Blood Glucose as a Predictor of Morbidity and Mortality in Polytraumatized Patients
Study Overview
Detailed Description
Trauma is still the leading cause of death in young adults and a major cause of morbidity and mortality at all ages.(1,2). Polytrauma is defined as injury to several physical regions or organ systems, where at least one injury or the combination of several injuries are life threatening with the severity of injury being equal or >16 on the scale of the Injury Severity Score (ISS). Prediction of mortality in trauma patients is an important part of trauma care (3). The trauma and injury severity score (TRISS) and Acute Physiology and Chronic Health Evaluation IV (APACHE IV) are used commonly to predict injury severity and risk of mortality. Although it is regarded as the international standard in trauma scoring, it has complex calculating and incorporates the Glasgow Coma Scale (GCS) for neurological evaluation (4). Regardless of the accuracy of trauma scores, is based on an anatomical description of every injury and cannot be assigned to the patients until a full diagnostic procedure has been performed(5) . Many studies have revealed alteration in glucose metabolism in trauma and proportional relation of its high level to the degree of injury (6). hyperglycaemia is associated with similar complications as uncontrolled diabetes, including an increased mortality, an increased number of infectious complications, and poor wound healing. The presence of elevated blood glucose also impedes normal host defences against infection and impairs the normal inflammatory response (7.8).
- Therefore, this study will be conducted to compare between alterations in easy and rapid predictors as glucose level, base deficit and lactate and difficult and slow predictors as TRISS and APACHE IV. So, it could be considered an early and easy rapid predictor of outcome .
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
• Age >= 18 years
- Polytrauma ISS >= 18
- Recent polytrauma patients who are directly transferred by the ambulance from the scene of accident to assiut university hospital and did not receive resuscitative measurements in another hospital
Exclusion Criteria:
known co-morbidities affecting blood glucose level like :
- Pregnant women
- Diabetic patients
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Admission blood glucose as a predictor of morbidity and mortality in polytraumatized patients
Time Frame: baseline
|
to investigate the admission blood glucose level as a predictor of morbidity and mortality in poly traumatized patients
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Admission blood glucose as a predictor of morbidity and mortality in polytraumatized patients
Time Frame: baseline
|
correlation of blood glucose level to serum lactate , interlukin6 , C reactive protein , coagulation profile and their use as biomarkers in polytraumatized patients
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hossam Abubeih, ass.prof, Assiut University
- Study Director: fasil adam, prof, Assiut University
Publications and helpful links
General Publications
- Laird AM, Miller PR, Kilgo PD, Meredith JW, Chang MC. Relationship of early hyperglycemia to mortality in trauma patients. J Trauma. 2004 May;56(5):1058-62. doi: 10.1097/01.ta.0000123267.39011.9f.
- Lichtveld RA, Panhuizen IF, Smit RB, Holtslag HR, van der Werken C. Predictors of Death in Trauma Patients who are Alive on Arrival at Hospital. Eur J Trauma Emerg Surg. 2007 Feb;33(1):46-51. doi: 10.1007/s00068-007-6097-6. Epub 2007 Feb 27. Erratum In: Eur J Trauma Emerg Surg. 2007 Apr;33(2):201.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- blood glucose
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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