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Stopping Cardiovascular Treatments and Mortality in a MICU (TRAM)

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ClinicalTrials.gov Identifier: NCT04121429
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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.

Condition or disease Intervention/treatment
Critical Care Medication Cardiovascular Diseases Outcome, Fatal 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).


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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact on Mortality of Cardiovascular Treatments Interruption in a Medical Intensive Care Unit
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : November 2, 2019
Estimated Study Completion Date : November 2, 2019

Intervention Details:
  • Other: Observation
    No intervention will be performed


Primary Outcome Measures :
  1. ICU Mortality [ Time Frame: 2 months following ICU Discharge ]
    Patients mortality will be assessed at the end of the ICU stay (two months)


Secondary Outcome Measures :
  1. Hospital mortality [ Time Frame: 2 months following Hospital Discharge ]
    Patients mortality will be assessed at the end of the hospitalisation stay (two months)

  2. Mortality at Month 3 following discharge [ Time Frame: 3-months following discharge ]
  3. Mortality at Month 6 following discharge [ Time Frame: 6-months following discharge ]
  4. Mortality at Month 12 (1-year) following discharge [ Time Frame: 12-months following discharge ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • All patients with cardiovascular treatment prior to ICU admission

Exclusion Criteria:

  • Data unavailability
  • Consent withdrawal following information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121429


Contacts
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Contact: Erwan L'HERr +33298347181 erwan.lher@chu-brest.fr
Contact: Margot GICQUEL +33298347181

Locations
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France
Medical Intensive Care Unit, Brest University Hospital Recruiting
Brest, France, 29200
Contact: Erwan L'HER    +33298347181    erwan.lher@chu-brest.fr   
Sponsors and Collaborators
University Hospital, Brest

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT04121429     History of Changes
Other Study ID Numbers: TRAM ( 29BRC19.0035)
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases