- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04121429
Stopping Cardiovascular Treatments and Mortality in a MICU (TRAM)
Impact on Mortality of Cardiovascular Treatments Interruption in a Medical Intensive Care Unit
Study Overview
Status
Intervention / Treatment
Detailed Description
Cardiovascular treatments should not be interrupted following hospital admission, in order to decrease patients' morbidity. However, following ICU admission, such treatments are frequently interrupted and/or modified.
Few studies have investigated the outcome impact of medications interruption and/or modifications following hospital admission. We did consider that it might be interesting to study whether treatment continuation, interruption, and/or re-introduction following ICU admission may modify patients' outcome either in the ICU or following hospital discharge (at 3,6 and 12 months).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Erwan L'HERr
- Phone Number: +33298347181
- Email: erwan.lher@chu-brest.fr
Study Contact Backup
- Name: Margot GICQUEL
- Phone Number: +33298347181
Study Locations
-
-
-
Brest, France, 29200
- Recruiting
- Medical Intensive Care Unit, Brest University Hospital
-
Contact:
- Erwan L'HER
- Phone Number: +33298347181
- Email: erwan.lher@chu-brest.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients with cardiovascular treatment prior to ICU admission
Exclusion Criteria:
- Data unavailability
- Consent withdrawal following information
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ICU Mortality
Time Frame: 2 months following ICU Discharge
|
Patients mortality will be assessed at the end of the ICU stay (two months)
|
2 months following ICU Discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital mortality
Time Frame: 2 months following Hospital Discharge
|
Patients mortality will be assessed at the end of the hospitalisation stay (two months)
|
2 months following Hospital Discharge
|
Mortality at Month 3 following discharge
Time Frame: 3-months following discharge
|
3-months following discharge
|
|
Mortality at Month 6 following discharge
Time Frame: 6-months following discharge
|
6-months following discharge
|
|
Mortality at Month 12 (1-year) following discharge
Time Frame: 12-months following discharge
|
12-months following discharge
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRAM ( 29BRC19.0035)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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