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NCT04332237 Clinical Trial

Meta-Analysis Accidental Hypothermia in Trauma

Trauma Clinical Trial

Official title:
The Impact of Accidental Hypothermia on Mortality in Trauma Patients Overall and Patients With Traumatic Brain Injury Specifically: A Systematic Review and Meta-Analysis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04332237
Other study ID # SRMA hypothermia trauma
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 12, 2019
Est. completion date January 21, 2020

Study information
Verified date March 2020
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a systematic literature review and meta-analysis investigating the effect of accidental hypothermia on mortality in trauma patients overall and patients with TBI specifically.

Literature search will be performed using the Ovid Medline/PubMed database. Studies comparing the effect of hypothermia vs. normothermia at hospital admission on in-hospital mortality will be included in meta-analysis.

Description:

Accidental hypothermia is a known predictor for worse outcomes in trauma patients, but has not been comprehensively assessed in meta-analysis so far. The aim of this systematic review and meta-analysis is to investigate the impact of accidental hypothermia on mortality in trauma patients overall and patients with traumatic brain injury (TBI) specifically.

Literature search will be conducted using the Ovid Medline/PubMed database. The search strategy will be based on the PICOS strategy.

Scientific articles reporting (1) accidental hypothermia in trauma patients overall or patients with TBI specifically, (2) body temperature and time of measurement, and (3) the impact of accidental hypothermia on outcomes will be included in the qualitative review.

Two meta-analyses will be performed including (1) trauma patients overall and (2) patients with TBI specifically. Studies reporting in-hospital mortality of hypothermic and normothermic trauma patients overall or patients with TBI specifically, based on the temperature measured at Emergency Department admission, will be included in meta-analysis. Meta-analysis will be performed using a Mantel-Haenszel random-effects model. The estimated effect size for mortality will be reported as odds ratio (OR) and 95% confidence interval (CI) for each study as well as for the overall cohort.

Recruitment information / eligibility
Status Completed
Enrollment 776684
Est. completion date January 21, 2020
Est. primary completion date January 21, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion criteria:

- Original scientific articles

- English language

- Study in trauma patients

- Reported body temperature and time of temperature measurement

- Reported impact of accidental hypothermia on outcomes

Exclusion criteria:

- Case reports

- Systematic reviews

- Articles on therapeutic hypothermia

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland Inselspital, Bern University Hospial Bern

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary In-hospital mortality Death occurring during the hospital stay From hospital admission to discharge, expected to be up to 4 weeks
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