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 30, 2011

Last verified: November 2011

History of Changes

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:

MedlinePlus related topics: Cardiac Arrest Hypothermia Oxygen Therapy Traumatic Brain Injury

U.S. FDA Resources

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 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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

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:

Nolan JP, Morley PT, Vanden Hoek TL, Hickey RW, Kloeck WG, Billi J, Bottiger BW, Morley PT, Nolan JP, Okada K, Reyes C, Shuster M, Steen PA, Weil MH, Wenzel V, Hickey RW, Carli P, Vanden Hoek TL, Atkins D; International Liaison Committee on Resuscitation. Therapeutic hypothermia after cardiac arrest: an advisory statement by the advanced life support task force of the International Liaison Committee on Resuscitation. Circulation. 2003 Jul 8;108(1):118-21. No abstract available.

Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63.

Macmillan CS, Andrews PJ. Cerebrovenous oxygen saturation monitoring: practical considerations and clinical relevance. Intensive Care Med. 2000 Aug;26(8):1028-36. Review.

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 30, 2011
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
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes

Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013

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