Cardiogenic ShockECMONCT05730881
Comparison of Four Intensive Care Scores in Prediction of VA-ECMO Survival.
An observational study of Cardiogenic Shock and Extracorporeal Membrane Oxygenation Complication, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
VA-ECMO is increasingly utilized in the setting of cardiogenic shock or cardiac arrest to restore hemodynamic stability and end organ function. VA-ECMO serves as a short-term ventricular assist device that can be rapidly placed at the bedside in the emergency room, intensive care unit, cardiac catheterization suite… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cardiogenic Shock, Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- ECMO
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteQatar
- Study dates
- 30 Mar 2023to 30 Nov 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be undertaken in the Cardiothoracic intensive care unit (CTICU) in the Heart hospital, Hamad Medical Corporation for patients who require VA-ECMO support
Who may be able to join
- Age more than18 years old.
- Patients undergoing institution of VA ECMO
Who cannot join
- Patients staying < 12 hours in the ICU
Trial locations and contacts
1 site in 1 country.
Praveen Sivadasan, MD contact
Qatar1 site, 1 recruiting
- Recruiting
Hamad medical corporation
Doha, DA, 3050
Suraj Sudarsanan, MD, ssudarsanan@hamad.qa
About this study
Official title: Comparison of Four Intensive Care Scores in Prediction of Survival After Veno-Arterial ECMO: A Single Center Retrospective Study
VA-ECMO is increasingly utilized in the setting of cardiogenic shock or cardiac arrest to restore hemodynamic stability and end organ function. VA-ECMO serves as a short-term ventricular assist device that can be rapidly placed at the bedside in the emergency room, intensive care unit, cardiac catheterization suite, or operating room. A bridge to decision approach allows for the assessment of neurologic status, renal and hepatic function, and subsequent recovery of cardiac function. Despite its life-saving potential, VA-ECMO is fraught with complications including vascular complications from cannulation. In addition, neurologic injury, renal failure, liver failure, and sepsis are all well described sequelae of the post-cardiogenic shock or cardiac arrest VA-ECMO patient. For these reasons, identifying early prognostic indicators and developing a score with regard to the outcome of this special patient population is of high interest. The proposed study aims to analyze 4 ICU scores/Survival prediction models [APACHE-II (acute physiology and chronic health evaluation II), SAVE (Survival after VA ECMO) , SOFA (sequential organ failure assessment )and CASUS (Cardiac Surgery Score)] and evaluate their performance in predicting survival after VA ECMO insertion. This will be a clinical retrospective study which will be conducted in the Cardiothoracic Intensive Care unit (CTICU) in the Department of Cardiothoracic Surgery, Heart Hospital, Doha. Patients admitted to the CTICU after institution of VA ECMO in the period between 1st January 2015 to 31st October 2022 will be screened retrospectively. Patients who stay for at least 12 hours in the CTICU would be eligible for inclusion in the study. All charts of patients who were admitted to CTICU after institution of VA ECMO during the afore mentioned period will be included in the review. All the risk scores would be calculated separately for all the enrolled patients and then subjected to statistical analysis to determine predictive accuracy for survival.
- Being tested
- ECMO
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMOProcedure or surgery
VA-ECMO is a life support measures, we need to estimate the survival by different techniques to allocate therapeutic interventions properly
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival predictive accuracy of four scores
Survival predictive accuracy of four scores
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start30 Mar 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suraj Sudarsanan, Md, Principal investigator, Hamad medical coproation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730881
- Sponsor's protocol ID
- MRC-01-22-701
- Acronym
- ECMO
- Status last verified
- Nov 2022
- First submitted
- 5 Dec 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Four Intensive Care Scores in Prediction of Survival After Veno-Arterial ECMO: A Single Center Retrospective Study
- ClinicalTrials.gov ID
- NCT05730881
- Acronym / sponsor ID
- ECMO / MRC-01-22-701
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 16 Feb 2023 (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.
VA-ECMO is increasingly utilized in the setting of cardiogenic shock or cardiac arrest to restore hemodynamic stability and end organ function. VA-ECMO serves as a short-term ventricular assist device that can be rapidly placed at the bedside in the emergency room, intensive care unit, cardiac catheterization suite, or operating room. A bridge to decision approach allows for the assessment of neurologic status, renal and hepatic function, and subsequent recovery of cardiac function. Despite its life-saving potential, VA-ECMO is fraught with complications including vascular complications from cannulation. In addition, neurologic injury, renal failure, liver failure, and sepsis are all well described sequelae of the post-cardiogenic shock or cardiac arrest VA-ECMO patient. For these reasons, identifying early prognostic indicators and developing a score with regard to the outcome of this special patient population is of high interest. The proposed study aims to analyze 4 ICU scores/Survival prediction models [APACHE-II (acute physiology and chronic health evaluation II), SAVE (Survival after VA ECMO) , SOFA (sequential organ failure assessment )and CASUS (Cardiac Surgery Score)] and evaluate their performance in predicting survival after VA ECMO insertion. This will be a clinical retrospective study which will be conducted in the Cardiothoracic Intensive Care unit (CTICU) in the Department of Cardiothoracic Surgery, Heart Hospital, Doha. Patients admitted to the CTICU after institution of VA ECMO in the period between 1st January 2015 to 31st October 2022 will be screened retrospectively. Patients who stay for at least 12 hours in the CTICU would be eligible for inclusion in the study. All charts of patients who were admitted to CTICU after institution of VA ECMO during the afore mentioned period will be included in the review. All the risk scores would be calculated separately for all the enrolled patients and then subjected to statistical analysis to determine predictive accuracy for survival.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be undertaken in the Cardiothoracic intensive care unit (CTICU) in the Heart hospital, Hamad Medical Corporation for patients who require VA-ECMO support
Key inclusion criteria (2 listed)
Key exclusion criteria (1 listed)
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 |
|---|---|---|
| ECMOVA-ECMO is a life support measures, we need to estimate the survival by different techniques to allocate therapeutic interventions properly | Procedure or surgery | – |
Primary outcome
Survival predictive accuracy of four scores
Time frame: 6 months
Survival predictive accuracy of four scores
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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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.
Praveen Sivadasan, MD contact
Suraj Sudarsanan, Md principal investigator
Hamad medical coproation
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 Cardiogenic Shock and Extracorporeal Membrane Oxygenation Complication, run by Hamad Medical Corporation at 1 site in Qatar.
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 2 inclusion and 1 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 28 Sep 2023. 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 Qatar. 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 Suraj Sudarsanan, MD (44395897, Sudarsanan@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival predictive accuracy of four scores (time frame: 6 months). 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 28 Sep 2023.