Cardiogenic ShockECPRNCT05730907
Efficacy and Clinical Outcomes of Levosimendan in E-CPR
An observational study of Cardiogenic Shock and Extracorporeal Membrane Oxygenation Complication, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
Treatment of refractory cardiac arrest requiring cardiopulmonary resuscitation (CPR) may be augmented with Extracorporeal membrane oxygenation (ECMO) to re-establish perfusion in the absence of return of spontaneous circulation. 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?
- Levosimendan
- How many people
- 100 participants
- Where
- 1 siteQatar
- Study dates
- 20 Feb 2023to 30 Apr 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
- Adult, Older adult
Study population: This study will retrospectively review the electronic medical records of patients who underwent E-CPR at HGH and HH. The units involved are Medical Intensive Care Unit at HGH and both intensive care units at HH i.e., Coronary and Cardiothoracic
Who may be able to join
None listed.
Who cannot join
- Patients with incomplete key data
- Criteria as per HMC's Extracorporeal Membrane Oxygenation (ECMO) for Cardiac Arrest (E-CPR) clinical practice guidelines (attached with the study protocol)
Trial locations and contacts
1 site in 1 country.
Qatar1 site, 1 recruiting
- Recruiting
Hamad medical corporation
Doha, DA, 3050
Rasha Kaddoura, rkaddoura@hamad.qa
About this study
Treatment of refractory cardiac arrest requiring cardiopulmonary resuscitation (CPR) may be augmented with Extracorporeal membrane oxygenation (ECMO) to re-establish perfusion in the absence of return of spontaneous circulation. Literature has demonstrated that ECMO initiated during advanced cardiopulmonary life support may confer superior survival rates with acceptable survival and a relatively low incidence of significant neurologic impairment. Levosimendan has not been investigated in patients with cardiac arrest who underwent Extracorporeal CPR (E-CPR). The current study aims to examine whether levosimendan use in the aforementioned patient population could improve survival and ECMO parameters.
- Being tested
- Levosimendan
- Keywords
- levosimendan, ECPR, neurological outcome
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevosimendanDrug
examine whether levosimendan could improve in-hospital survival with good neurological outcomes in patients with cardiac arrest supported by E-CPR
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to hospital discharge
Survival to hospital discharge with good neurological outcomes
Measured: 6 months
Secondary outcomes (2)
Survival to decannulation
Survival to decannulation with good neurological outcomes
Measured: 6 months
long term survival
long term survival
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 start20 Feb 2023 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rasha Kaddoura, Principal investigator, Hamad medical coproation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730907
- Sponsor's protocol ID
- MRC-01-21-282
- Acronym
- ECPR
- Status last verified
- Nov 2022
- First submitted
- 5 Dec 2022
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: as per hospital rules and regulations
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Clinical Outcomes of Levosimendan in E-CPR
- ClinicalTrials.gov ID
- NCT05730907
- Acronym / sponsor ID
- ECPR / MRC-01-21-282
- Keywords
- levosimendan, ECPR, neurological outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2023 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 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.
Treatment of refractory cardiac arrest requiring cardiopulmonary resuscitation (CPR) may be augmented with Extracorporeal membrane oxygenation (ECMO) to re-establish perfusion in the absence of return of spontaneous circulation. Literature has demonstrated that ECMO initiated during advanced cardiopulmonary life support may confer superior survival rates with acceptable survival and a relatively low incidence of significant neurologic impairment. Levosimendan has not been investigated in patients with cardiac arrest who underwent Extracorporeal CPR (E-CPR). The current study aims to examine whether levosimendan use in the aforementioned patient population could improve survival and ECMO parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will retrospectively review the electronic medical records of patients who underwent E-CPR at HGH and HH. The units involved are Medical Intensive Care Unit at HGH and both intensive care units at HH i.e., Coronary and Cardiothoracic
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Patients with incomplete key data
- Criteria as per HMC's Extracorporeal Membrane Oxygenation (ECMO) for Cardiac Arrest (E-CPR) clinical practice guidelines (attached with the study protocol)
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 |
|---|---|---|
| Levosimendanexamine whether levosimendan could improve in-hospital survival with good neurological outcomes in patients with cardiac arrest supported by E-CPR | Drug | – |
Primary outcome
Survival to hospital discharge
Time frame: 6 months
Survival to hospital discharge with good neurological outcomes
2 secondary outcomes
Survival to decannulation
Time frame: 6 months
long term survival
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: No. as per hospital rules and regulations
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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.
Rasha Kaddoura 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 0 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 16 Feb 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 Rasha Kaddoura, Msc (44395897, rasha.kaddoura@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival to hospital discharge (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 16 Feb 2023.