Refractory IHCA and OHCA Treated With ECMO

Cardiac Arrest Clinical Trial

— SEAC  

Official title:

Refractory In and Out of Hospital Cardiac Arrest Treated With Extracorporeal Membrane Oxygenation. Observational, Single Centre, Prospective Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01298050
• Other study ID #: AOSG-TICCH-01-2011
• Status: Recruiting
• Phase: N/A
• First received: February 16, 2011
• Last updated: August 3, 2011
• Start date: July 2011
• Est. completion date: July 2013

Study information

• Verified date: July 2011
• Source: University of Milano Bicocca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Procedure:
• ECMO
Insertion of peripheral Veno-Arterious ECMO, subsequent therapeutic hypothermia

Locations

Country	Name	City	State
Italy	San Gerardo Hospital	Monza	MB

Sponsors (3)

Lead Sponsor	Collaborator
University of Milano Bicocca	Ospedale San Gerardo. S.S.U.E.M. 118 Brianza, Ospedale San Gerardo. Terapia Intensiva Cardiochirurgica

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28 days survival		28 days	No
Secondary	Neurologic recovery	Neurologic recovery defined as minimal neurologic impairment according to the Glasgow-Pittsburgh cerebral performance categories score = 2.	28 days	No
Secondary	Cardiac recovery	Measured by echocardiography	28 days	No
Secondary	Six months survival with minimal neurologic impairment	survival with minimal neurologic impairment according to the Glasgow-Pittsburgh cerebral performance categories score = 2.	180 days	No