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OpenTrials
Completed

NCT Number: NCT04332237

Meta-Analysis Accidental Hypothermia in Trauma

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. In-hospital mortality

    Time frame: From hospital admission to discharge, expected to be up to 4 weeks

    Death occurring during the hospital stay

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 2, 2020
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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