Iatrogenic Withdrawal SymptomesNCT04320927
Iatrogenic Withdrawal Symptoms in Severe Traumatic Brain Injury
An observational study of Iatrogenic Withdrawal Symptomes, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iatrogenic Withdrawal Symptomes
- How many people
- 215 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2020to 1 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Severe TBI defined as traumatic brain injury that required admission to the neuro-ICU.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Neuroanaesthesiology
Copenhagen, Capital Region, 2200
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with positive IWS diagnosis
Measured: 20-6-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 Mar 2020
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iatrogenic Withdrawal SymptomesStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus Harboe Olsen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320927
- Sponsor's protocol ID
- 5798001020855
- Status last verified
- Apr 2020
- First submitted
- 23 Mar 2020
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iatrogenic Withdrawal Symptoms in Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT04320927
- Acronym / sponsor ID
- 5798001020855
- Conditions
- Iatrogenic Withdrawal Symptomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severe TBI defined as traumatic brain injury that required admission to the neuro-ICU.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
proportion of patients with positive IWS diagnosis
Time frame: 20-6-2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iatrogenic Withdrawal Symptomes, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients with positive IWS diagnosis (time frame: 20-6-2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.