Refractory IHCA and OHCA Treated With ECMO

NCT ID: NCT01298050

Last Updated: 2011-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-07-31

Brief Summary

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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

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Conditions

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Cardiac Arrest

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Extracorporeal Membrane Oxygenation

All patients have to start ECMO under CPR, by insertion of peripheral VA cannulas.

ECMO

Intervention Type PROCEDURE

Insertion of peripheral Veno-Arterious ECMO, subsequent therapeutic hypothermia

Interventions

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ECMO

Insertion of peripheral Veno-Arterious ECMO, subsequent therapeutic hypothermia

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale San Gerardo. S.S.U.E.M. 118 Brianza

UNKNOWN

Sponsor Role collaborator

Ospedale San Gerardo. Terapia Intensiva Cardiochirurgica

UNKNOWN

Sponsor Role collaborator

University of Milano Bicocca

OTHER

Sponsor Role lead

Responsible Party

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University of Milano Bicocca

Principal Investigators

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Leonelllo Avalli, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale San Gerardo

Locations

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San Gerardo Hospital

Monza, MB, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Leonello Avalli, MD

Role: primary

0039392334330

Roberto Fumagalli, MD

Role: backup

0039392339294

Other Identifiers

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AOSG-TICCH-01-2011

Identifier Type: -

Identifier Source: org_study_id

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