Stopping Cardiovascular Treatments and Mortality in a MICU

NCT04121429 | Unknown

• 1 other identifier: TRAM ( 29BRC19.0035)
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Care; Medication; Cardiovascular Diseases; Outcome, Fatal

Outcome Measures

Primary Outcomes (1)

• ICU Mortality

  Patients mortality will be assessed at the end of the ICU stay (two months)

  2 months following ICU Discharge

Secondary Outcomes (4)

• Hospital mortality

  2 months following Hospital Discharge

• Mortality at Month 3 following discharge

  3-months following discharge

• Mortality at Month 6 following discharge

  6-months following discharge

• Mortality at Month 12 (1-year) following discharge

  12-months following discharge

Interventions

Observation OTHER

No intervention will be performed

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Data will be extracted from the computerized medical datafile All patients with a medical history of cardiovascular disease and medication will be included within the time frame of the study All types of cardiovascular treatment will be considered: antiarrythmic drugs, anticoagulant and platelet aggregation inhibitors, vasodilators, inotropic drugs, antihypertensive agents, betablockers, statins

You may qualify if:

• All patients with cardiovascular treatment prior to ICU admission

You may not qualify if:

• Data unavailability
• Consent withdrawal following information

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Medical Intensive Care Unit, Brest University Hospital

Brest, 29200, France

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Erwan L'HERr

CONTACT

+33298347181; erwan.lher@chu-brest.fr

Margot GICQUEL

CONTACT

+33298347181

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 9, 2019
• Study Start: May 2, 2019
• Primary Completion: November 2, 2019
• Study Completion: November 2, 2019
• Last Updated: October 9, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning six months and ending five years following the publication
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)