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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Davide Chiumello, Policlinico Hospital
ClinicalTrials.gov Identifier:
NCT00870610
First received: March 10, 2009
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Hypoxic Brain Injury
Hypothermia
Procedure: retrograde jugular venous cannulation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cerebral Metabolism During Therapeutic Hypothermia for Cardiac Arrest

Resource links provided by NLM:


Further study details as provided by Policlinico Hospital:

Biospecimen Retention:   Samples With DNA

whole blood


Estimated Enrollment: 15
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: retrograde jugular venous cannulation
    Retrograde cannulation of jugular vein and intermittent sampling of venous blood from cerebral circulation before, during and after hypothermia.
    Other Name: SjO2, cerebrovenous oxygen saturation
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870610

Locations
Italy
Intensive Care Unit-Fondazione Ospedale Maggiore Policlinico Mangiagalli Regina Elena
Milan, Italy, 20122
Sponsors and Collaborators
Policlinico Hospital
Investigators
Principal Investigator: Davide Chiumello, MD Fondazione Ospedale Maggiore Policlinico Mangiagalli Regina Elena
  More Information

Publications:
Responsible Party: Davide Chiumello, MD, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT00870610     History of Changes
Other Study ID Numbers: 2010
Study First Received: March 10, 2009
Last Updated: November 13, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Policlinico Hospital:
jugular venous oxygen saturation
hypothermia

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Brain Injuries
Hypoxia, Brain
Wounds and Injuries
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 24, 2014