Efficacy and Clinical Outcomes of Levosimendan in E-CPR

NCT05730907 | Unknown DMC

• 1 other identifier: MRC-01-21-282
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiogenic Shock; Extracorporeal Membrane Oxygenation Complication

Keywords

levosimendan; ECPR; neurological outcome

Outcome Measures

Primary Outcomes (1)

• Survival to hospital discharge

  Survival to hospital discharge with good neurological outcomes

  6 months

Secondary Outcomes (2)

• Survival to decannulation

  6 months

• long term survival

  6 months

Interventions

Levosimendan DRUG

examine whether levosimendan could improve in-hospital survival with good neurological outcomes in patients with cardiac arrest supported by E-CPR

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad medical corporation

Doha, DA, 3050, Qatar

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Interventions

Simendan

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rasha Kaddoura

  Hamad medical coproation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rasha Kaddoura, Msc

CONTACT

44395897; rasha.kaddoura@gmail.com

Bssant Orabi, Msc

CONTACT

44395897; bassantorabi@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: February 16, 2023
• Study Start: February 20, 2023
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: February 16, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)