Functional Outcome After Cardiac Arrest (HANOX)

August 17, 2020 updated by: Assistance Publique - Hôpitaux de Paris

Functional Outcome After Cardiac Arrest; Prediction and Prognosis Factors for Patients Awake Within the First 15 Days

Descriptive and prognosis study of the functional outcome after cardiac arrest for the patients awake within the first 15 days.

Study Overview

Status

Completed

Conditions

Detailed Description

Functional outcome after cerebral anoxia due to cardiac arrest is poorly documented.. Survival after out of hospital cardiac arrest has improved and long term follow up of the patients is not routinely effective. Patients showing sign of awakening very early are considered in a good outcome group. Nevertheless they can experience some restriction and difficulties when they try to return to their premorbid level of functioning.

We aim to study their long term functional outcome and their level of anxiety, depression, quality of life and caregiver burden as well as their general cognitive functioning. Prognosis factors will be studied in the acute phase.

Study Type

Observational

Enrollment (Actual)

140

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

  • France
      • Paris, France, 75013
        • Pitié Salpétrière Hospital

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 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients presenting an Out of hospital cardiac arrest

Description

Inclusion criteria :

  • age 18 to 85
  • Out of hospital cardiac arrest ; cardiac arrest in the ER is eligible
  • Glasgow Coma Score ≥ 12 within 15 days after onset
  • Living in the parisian area

Exclusion criteria :

  • no social security
  • Neurological condition (multiple sclerosis, parkinson disease, AMS, stroke) priori to the cardiac arrest
  • Psychiatric condition (schizophrenia, severe bipolar syndrome, long term neuroleptic medication, autistic spectrum disorders
  • Deafness and blindness
  • Neoplasia
  • Premorbid limitation of autonomy.
  • Difficulties in speaking and writing the French language

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glasgow outcome Scale Extended score
Time Frame: 18 months
Functional outcome at 18 months
18 months

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Director: Anne Peskine, MD, Assistance Publique - Hôpitaux de Paris
  • Principal Investigator: Charles-Edouard Luyt, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 13, 2013

Primary Completion (Actual)

October 20, 2017

Study Completion (Actual)

October 20, 2017

Study Registration Dates

First Submitted

November 12, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (Estimate)

November 17, 2014

Study Record Updates

Last Update Posted (Actual)

August 19, 2020

Last Update Submitted That Met QC Criteria

August 17, 2020

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P111012

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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