Stopping Cardiovascular Treatments and Mortality in a MICU

Cardiovascular Diseases Clinical Trial

— TRAM  

Official title:

Impact on Mortality of Cardiovascular Treatments Interruption in a Medical Intensive Care Unit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04121429
• Other study ID #: TRAM ( 29BRC19.0035)
• Status: Recruiting
• Start date: May 2, 2019
• Est. completion date: November 2, 2019

Study information

• Verified date: April 2019
• Source: University Hospital, Brest
• Contact: Erwan L'HERr
• Phone: +33298347181
• Email: erwan.lher[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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. The question of the study is to investigate wether such treatment interruption might be responsible for prognosis modifications.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 2, 2019
• Est. primary completion date: November 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• All patients with cardiovascular treatment prior to ICU admission

Exclusion Criteria:

• Data unavailability

• Consent withdrawal following information

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Critical Care
• Medication
• Outcome, Fatal

Intervention

Other:
• Observation
No intervention will be performed

Locations

Country	Name	City	State
France	Medical Intensive Care Unit, Brest University Hospital	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU Mortality	Patients mortality will be assessed at the end of the ICU stay (two months)	2 months following ICU Discharge
Secondary	Hospital mortality	Patients mortality will be assessed at the end of the hospitalisation stay (two months)	2 months following Hospital Discharge
Secondary	Mortality at Month 3 following discharge		3-months following discharge
Secondary	Mortality at Month 6 following discharge		6-months following discharge
Secondary	Mortality at Month 12 (1-year) following discharge		12-months following discharge