Stopping Cardiovascular Treatments and Mortality in a MICU (TRAM)

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

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases; Critical Care; Outcome, Fatal; Medication
• Intervention / Treatment: Other: Observation

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: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• France
  • 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: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU Mortality	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	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		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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2019
• Primary Completion (Anticipated): November 2, 2019
• Study Completion (Anticipated): November 2, 2019

Study Registration Dates

• First Submitted: October 4, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): October 9, 2019
• Last Update Submitted That Met QC Criteria: October 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: TRAM ( 29BRC19.0035)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning six months and ending five years following the publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No