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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04100369
Other study ID # blood glucose
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2020

Study information

Verified date September 2019
Source Assiut University
Contact tamer armanious, MD
Phone +201203523938
Email tamerrefaat2244@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

In polytrraumatized patients, Does hyperglycaemia on admission increase the risk of morbidity and mortality compared to polytraumatised patients with normal blood glucose level ?


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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 31, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
laboratory
Arm

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Admission blood glucose as a predictor of morbidity and mortality in polytraumatized patients to investigate the admission blood glucose level as a predictor of morbidity and mortality in poly traumatized patients baseline
Secondary Admission blood glucose as a predictor of morbidity and mortality in polytraumatized patients correlation of blood glucose level to serum lactate , interlukin6 , C reactive protein , coagulation profile and their use as biomarkers in polytraumatized patients baseline
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