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Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Valve Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01685554
First Posted: September 14, 2012
Last Update Posted: October 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Northern State Medical University
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Combined Valve Surgery: Single Center, Randomized Trial

Resource links provided by NLM:


Further study details as provided by Northern State Medical University:

Primary Outcome Measures:
  • Cerebral oxygen saturation [ Time Frame: perioperatively ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • requirement of surgical correction of two or more valves
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 4, 2012
First Posted: September 14, 2012
Last Update Posted: October 18, 2012
Last Verified: October 2012

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

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