Iatrogenic Withdrawal Symptoms in Severe Traumatic Brain Injury

April 23, 2020 updated by: Markus Harboe Olsen, Rigshospitalet, Denmark
Iatrogenic withdrawal symptomes has been associated with prolonged mechanical ventilation and the and the derived symptoms such as fever and agitation has been shown to cause significantly prolonged ICU and hospital length of stay. The incidence of IWS in the adult general ICU ranges from 16,7-55%. To this date, the incidence of IWS has not been studied in patients with TBI.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

215

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2200
        • Department of Neuroanaesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Severe TBI defined as traumatic brain injury that required admission to the neuro-ICU.

Description

Inclusion Criteria:

  • adult patients suffering from severe TBI and were mechanical ventilated and received continuous infusions of opioids, benzodiazepines and neuromuscular blocking agents for 72ours or more

Exclusion Criteria:

  • age <18 years, patients who died before discharge, chronic alcohol abuse, regular use of heroin, cocaine and amphetamines, chronic use of opioids, patient that were primary admitted to other ICUs and patients that were moved to other ICUs with ongoing infusions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
proportion of patients with positive IWS diagnosis
Time Frame: 20-6-2019
20-6-2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

March 23, 2020

First Submitted That Met QC Criteria

March 24, 2020

First Posted (Actual)

March 25, 2020

Study Record Updates

Last Update Posted (Actual)

April 27, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5798001020855

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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