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Refractory IHCA and OHCA Treated With ECMO (SEAC)

This study is currently recruiting participants.
Verified July 2011 by University of Milano Bicocca
Sponsor:
Collaborators:
Ospedale San Gerardo. S.S.U.E.M. 118 Brianza
Ospedale San Gerardo. Terapia Intensiva Cardiochirurgica
Information provided by:
University of Milano Bicocca
ClinicalTrials.gov Identifier:
NCT01298050
First received: February 16, 2011
Last updated: August 3, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Cardiac Arrest
 Procedure: ECMO

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Refractory In and Out of Hospital Cardiac Arrest Treated With Extracorporeal Membrane Oxygenation. Observational, Single Centre, Prospective Study.

Resource links provided by NLM:

MedlinePlus related topics: Cardiac Arrest
U.S. FDA Resources

Further study details as provided by University of Milano Bicocca:

Primary Outcome Measures:
  • 28 days survival [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurologic recovery [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Neurologic recovery defined as minimal neurologic impairment according to the Glasgow-Pittsburgh cerebral performance categories score ≤ 2.

  • Cardiac recovery [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Measured by echocardiography

  • Six months survival with minimal neurologic impairment [ Time Frame: 180 days ] [ Designated as safety issue: No ]
    survival with minimal neurologic impairment according to the Glasgow-Pittsburgh cerebral performance categories score ≤ 2.


Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults 18-75 years old, community sample

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298050

Locations
Italy
San Gerardo Hospital Recruiting
Monza, MB, Italy, 20052
Contact: Leonello Avalli, MD     0039392334330     l.avalli@hsgerardo.org    
Contact: Roberto Fumagalli, MD     0039392339294     r.fumagalli@hsgerardo.org    
Principal Investigator: Leonello Avalli, MD            
Sponsors and Collaborators
University of Milano Bicocca
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
  More Information

No publications provided

Responsible Party: Roberto Fumagalli, University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT01298050     History of Changes
Other Study ID Numbers: AOSG-TICCH-01-2011
Study First Received: February 16, 2011
Last Updated: August 3, 2011
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013