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Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Valve Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Northern State Medical University
ClinicalTrials.gov Identifier:
NCT01685554
First received: September 4, 2012
Last updated: October 17, 2012
Last verified: October 2012
History of Changes
  Purpose

The aim of our study was to evaluate the effect of different temperature regimens of cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during surgical correction of acquired heart diseases.


Condition Intervention
Heart Valve Diseases
 Device: hypothermic CPB
Device: normothermic CPB

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Combined Valve Surgery: Single Center, Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northern State Medical University:

Primary Outcome Measures:
  • Cerebral oxygen saturation [ Time Frame: perioperatively ] [ Designated as safety issue: No ]
    measurement of cerebral oxygen saturation during cardiopulmonary bypass and 24 hrs postoperatively


Secondary Outcome Measures:
  • time until "fit for ICU discharge" fulfillment [ Time Frame: 5 days postoperatively ] [ Designated as safety issue: No ]
    measurement of time to fulfillment of the "fit for discharge" criteria


Enrollment: 40
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: normothermic CPB
cardiopulmonary bypass with maintenance of normal body temperature
 Device: normothermic CPB
maintenance of normal body temperature during cardiopulmonary bypass
Active Comparator: hypothermic CPB
cardiopulmonary bypass using mild hypothermia
 Device: hypothermic CPB
maintenance of mild hypothermia during cardiopulmonary bypass

Detailed Description:

Our aim was to evaluate the effect of hypothermic and normothermic regimens of cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during valve surgery

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • requirement of surgical correction of two or more valves
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685554

Locations
Russian Federation
Dep. of Anesthesiology, Northern SMU
Arkhangelsk, Russian Federation, 163000
Sponsors and Collaborators
Northern State Medical University
Investigators
Study Director: Mikhail Y Kirov, MD, PhD Northern State Medical Univercity
  More Information

No publications provided by Northern State Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Northern State Medical University
ClinicalTrials.gov Identifier: NCT01685554     History of Changes
Other Study ID Numbers: Norm-Arh-2012
Study First Received: September 4, 2012
Last Updated: October 17, 2012
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Northern State Medical University:
perfusion
cardiopulmonary bypass
hypothermia
cerebral oxygenation

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013