Critical CareTRAMNCT04121429
Stopping Cardiovascular Treatments and Mortality in a MICU
An observational study of Critical Care and Medication, run by University Hospital, Brest at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Critical Care, Medication, Cardiovascular Diseases
- What is being tested?
- Observation
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2019to 2 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- All patients with cardiovascular treatment prior to ICU admission
Who cannot join
- Data unavailability
- Consent withdrawal following information
Trial locations and contacts
1 site in 1 country.
Margot GICQUEL contact
France1 site, 1 recruiting
- Recruiting
Medical Intensive Care Unit, Brest University Hospital
Brest, 29200
Erwan L'HER, +33298347181, erwan.lher@chu-brest.fr
About this study
Official title: 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.
Read the 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).
- Conditions
- Critical Care, Medication, Cardiovascular Diseases, Outcome, Fatal
- Being tested
- Observation
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
No intervention will be performed
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Mortality
Patients mortality will be assessed at the end of the ICU stay (two months)
Measured: 2 months following ICU Discharge
Secondary outcomes (4)
Hospital mortality
Patients mortality will be assessed at the end of the hospitalisation stay (two months)
Measured: 2 months following Hospital Discharge
Mortality at Month 3 following discharge
Measured: 3-months following discharge
Mortality at Month 6 following discharge
Measured: 6-months following discharge
Mortality at Month 12 (1-year) following discharge
Measured: 12-months following discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start2 May 2019
- Primary completion2 Nov 2019 (estimated)
- Study completion2 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121429
- Sponsor's protocol ID
- TRAM ( 29BRC19.0035)
- Acronym
- TRAM
- Status last verified
- Apr 2019
- First submitted
- 4 Oct 2019
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Mortality of Cardiovascular Treatments Interruption in a Medical Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04121429
- Acronym / sponsor ID
- TRAM / TRAM ( 29BRC19.0035)
- Conditions
- Critical Care, Medication, Cardiovascular Diseases, Outcome, Fatal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 2 May 2019 (actual)
- Primary completion
- 2 Nov 2019 (estimated)
- Study completion
- 2 Nov 2019 (estimated)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All patients with cardiovascular treatment prior to ICU admission
Key exclusion criteria (2 listed)
- Data unavailability
- Consent withdrawal following information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationNo intervention will be performed | Other | – |
Primary outcome
ICU Mortality
Time frame: 2 months following ICU Discharge
Patients mortality will be assessed at the end of the ICU stay (two months)
4 secondary outcomes
Hospital mortality
Time frame: 2 months following Hospital Discharge
Mortality at Month 3 following discharge
Time frame: 3-months following discharge
Mortality at Month 6 following discharge
Time frame: 6-months following discharge
Mortality at Month 12 (1-year) following discharge
Time frame: 12-months following discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margot GICQUEL contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Care and Medication, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erwan L'HERr (+33298347181, erwan.lher@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Mortality (time frame: 2 months following ICU Discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.