ECPR: Efficacy and Clinical Outcomes of Levosimendan in E-CPR

• Sponsor: Hamad Medical Corporation (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05730907
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 2.3
• Patients Per Site Per Month: 44.1

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiogenic Shock; Extracorporeal Membrane Oxygenation Complication	Drug: Levosimendan

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Efficacy and Clinical Outcomes of Levosimendan in E-CPR
• Anticipated Study Start Date: Feb 20, 2023
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: Apr 30, 2023

Outcome Measures

Primary Outcome Measures

1. Survival to hospital discharge [6 months]

   Survival to hospital discharge with good neurological outcomes

Secondary Outcome Measures

1. Survival to decannulation [6 months]

   Survival to decannulation with good neurological outcomes

2. long term survival [6 months]

   long term survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All

IInclusion criteria:

• Hospitalized patients ≥ 18 years of age at the time of E-CPR use

• Patients suffered cardiac arrest (IHCA or OHCA)

• Patients received VA-ECMO for E-CPR

• Criteria as per HMC's Extracorporeal Membrane Oxygenation (ECMO) for Cardiac Arrest (E-CPR) clinical practice guidelines (attached with the study protocol)

Exclusion criteria:

• 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hamad medical corporation	Doha	DA	Qatar	3050

Sponsors and Collaborators

• Hamad Medical Corporation

Investigators

• Principal Investigator: Rasha Kaddoura, Hamad medical coproation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hamad Medical Corporation
• ClinicalTrials.gov Identifier: NCT05730907
• Other Study ID Numbers: MRC-01-21-282
• First Posted: Feb 16, 2023
• Last Update Posted: Feb 16, 2023
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hamad Medical Corporation: levosimendan; ECPR; neurological outcome
• Additional relevant MeSH terms: Shock, Cardiogenic; Simendan

Study Results

No Results Posted as of Feb 16, 2023