Jugular Venous Oxygen Saturation During Therapeutic Hypothermia After Cardiac Arrest (SjO2)

April 27, 2015 updated by: Davide Chiumello, Policlinico Hospital

Cerebral Metabolism During Therapeutic Hypothermia for Cardiac Arrest

The purpose of this study is to understand what happens to cerebral metabolism during therapeutic hypothermia for hypoxic brain injury following cardiac arrest.

Study Overview

Status

Completed

Detailed Description

Latest international guidelines recommend the use of therapeutic hypothermia in patients who have had cardiac arrest and remain in coma after return of spontaneous circulation. This is recommended essentially to limit the cerebral injury caused by cardiac arrest and possibly amplified upon reperfusion. At times, although a spontaneous circulation has returned, cerebral oxygenation may remain inadequate due to inadequate perfusion pressure, and hypothermia, by reducing cardiac output and cerebral blood flow could actually aggravate this phenomenon. The rewarming period is thought to be at greatest risk of inadequate oxygenation for the increase in metabolic demand. With this study we aim to understand what happens to cerebral oxygenation and metabolism during therapeutic hypothermia for cardiac arrest through cerebrovenous oxygen saturation monitoring and in particular, to see whether through this type of monitoring we could recognize otherwise unnoticed periods of inadequate cerebral oxygenation.

Study Type

Observational

Enrollment (Actual)

15

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

      • Milan, Italy, 20122
        • Intensive Care Unit-Fondazione Ospedale Maggiore Policlinico Mangiagalli Regina Elena

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

Adult patients who are in coma after cardiac arrest, admitted to the Intensive Care Unit of a University Teaching Hospital and undergoing therapeutic hypothermia

Description

Inclusion Criteria:

  • Adult patients in coma after cardiac arrest undergoing therapeutic hypothermia

Exclusion Criteria:

  • Age < 18
  • Pregnancy
  • Traumatic brain injury
  • Contraindications to cannulation as severe coagulopathy

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Davide Chiumello, MD, Fondazione Ospedale Maggiore Policlinico Mangiagalli Regina Elena

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.

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

November 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 10, 2009

First Submitted That Met QC Criteria

March 26, 2009

First Posted (Estimate)

March 27, 2009

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 27, 2015

Last Verified

April 1, 2015

More Information

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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