Refractory IHCA and OHCA Treated With ECMO

• Conditions: Cardiac Arrest
• Interventions: Procedure: ECMO

• Registration Number: NCT01298050
• Lead Sponsor: University of Milano Bicocca

Brief Summary

Extracorporeal membrane oxygenation (ECMO) support has been suggested to improve the survival rate in patients with refractory cardiac arrest (CA). Recent studies have also highlighted the potential early application of this method in improving the prognosis of prolonged cardiac arrest both for in hospital CA (INHCA) and out of hospital CA (OHCA). The rationale for use of ECMO in these patients is to optimize early perfusion of vital organs, curing the cause of CA and waiting for the recovery of the injured myocardium. The investigators have created a flow-chart to decide which patients are eligible. The aims of this study are to evaluate if, with this flow-chart, the investigators are able to detect which patients have more probability of survival.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-17
• Status Verified: 2011-07
• Study Start: 2011-07
• Last Update Submitted: 2011-08-03
• Last Update Posted: 2011-08-04
• Primary Completion: 2012-07
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adults 18-75 years old
• In and out of hospital Witnessed Cardiac Arrest
• No-flow time < 5 min. or VF,VT,TP as rhythm of presentation
• Low-flow time < 45 min.
• End Tidal CO2 > 10 after 20 min.of CPR

Exclusion Criteria

• Comorbidities such:
• Terminal Malignancy
• Aortic Dissection
• Severe Cardiac Failure without transplant indication
• Severe Aortic Valve Failure
• Known Severe Peripheral arteriopathy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Extracorporeal Membrane Oxygenation	ECMO	All patients have to start ECMO under CPR, by insertion of peripheral VA cannulas.

Primary Outcome Measures

Name	Time	Method
28 days survival	28 days

Secondary Outcome Measures

Name	Time	Method
Neurologic recovery	28 days	Neurologic recovery defined as minimal neurologic impairment according to the Glasgow-Pittsburgh cerebral performance categories score ≤ 2.
Cardiac recovery	28 days	Measured by echocardiography
Six months survival with minimal neurologic impairment	180 days	survival with minimal neurologic impairment according to the Glasgow-Pittsburgh cerebral performance categories score ≤ 2.

Trial Locations

Locations (1)

San Gerardo Hospital; 🇮🇹 Monza, MB, Italy