Iatrogenic Withdrawal Symptomes Clinical Trial
Official title:
Iatrogenic Withdrawal Symptoms in Severe Traumatic Brain Injury
| Verified date | April 2020 |
| Source | Rigshospitalet, Denmark |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 215 |
| Est. completion date | August 1, 2020 |
| Est. primary completion date | August 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Department of Neuroanaesthesiology | Copenhagen | Capital Region |
| Lead Sponsor | Collaborator |
|---|---|
| Rigshospitalet, Denmark |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | proportion of patients with positive IWS diagnosis | 20-6-2019 |