Jugular Venous Oxygen Saturation During Therapeutic Hypothermia After Cardiac Arrest

Hypothermia Clinical Trial

— SjO2  

Official title:

Cerebral Metabolism During Therapeutic Hypothermia for Cardiac Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870610
• Other study ID #: 2010
• Status: Completed
• Phase: N/A
• First received: March 10, 2009
• Last updated: April 27, 2015
• Start date: November 2011
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Policlinico Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Arrest
• Hypothermia
• Hypoxic Brain Injury

Intervention

Procedure:
• retrograde jugular venous cannulation
Retrograde cannulation of jugular vein and intermittent sampling of venous blood from cerebral circulation before, during and after hypothermia.

Locations

Country	Name	City	State
Italy	Intensive Care Unit-Fondazione Ospedale Maggiore Policlinico Mangiagalli Regina Elena	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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

Nolan JP, Morley PT, Vanden Hoek TL, Hickey RW, Kloeck WG, Billi J, Böttiger 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. — View Citation