Iatrogenic Withdrawal Symptoms in Severe Traumatic Brain Injury

NCT ID: NCT04320927

Last Updated: 2020-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 215 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2020-08-01

Brief Summary

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.

Conditions

Iatrogenic Withdrawal Symptomes

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Markus Harboe Olsen

md

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Neuroanaesthesiology

Copenhagen, Capital Region, Denmark

Countries

Denmark

Other Identifiers

5798001020855

Identifier Type: -

Identifier Source: org_study_id