Refractory IHCA and OHCA Treated With ECMO (SEAC)

August 3, 2011 updated by: University of Milano Bicocca

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MB
      • Monza, MB, Italy, 20052
        • Recruiting
        • San Gerardo Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Leonello Avalli, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults 18-75 years old, community sample

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Extracorporeal Membrane Oxygenation
All patients have to start ECMO under CPR, by insertion of peripheral VA cannulas.
Procedure: ECMO
Insertion of peripheral Veno-Arterious ECMO, subsequent therapeutic hypothermia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
28 days survival
Time Frame: 28 days
28 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milano Bicocca

Collaborators

Ospedale San Gerardo. S.S.U.E.M. 118 Brianza
Ospedale San Gerardo. Terapia Intensiva Cardiochirurgica

Investigators

  • Principal Investigator: Leonelllo Avalli, MD, Ospedale San Gerardo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

February 16, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (Estimate)

February 17, 2011

Study Record Updates

Last Update Posted (Estimate)

August 4, 2011

Last Update Submitted That Met QC Criteria

August 3, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOSG-TICCH-01-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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