Back to resultsNormothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Valve Surgery
Primary Purpose
Heart Valve Diseases
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
hypothermic CPB
normothermic CPB
Sponsored by
About this trial
This is an interventional treatment trial for Heart Valve Diseases focused on measuring perfusion, cardiopulmonary bypass, hypothermia, cerebral oxygenation
Eligibility Criteria
Inclusion Criteria:
- requirement of surgical correction of two or more valves
Sites / Locations
- Dep. of Anesthesiology, Northern SMU
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
normothermic CPB
hypothermic CPB
Arm Description
cardiopulmonary bypass with maintenance of normal body temperature
cardiopulmonary bypass using mild hypothermia
Outcomes
Primary Outcome Measures
Cerebral oxygen saturation
measurement of cerebral oxygen saturation during cardiopulmonary bypass and 24 hrs postoperatively
Secondary Outcome Measures
time until "fit for ICU discharge" fulfillment
measurement of time to fulfillment of the "fit for discharge" criteria
Full Information
NCT ID
NCT01685554
First Posted
September 4, 2012
Last Updated
October 17, 2012
Sponsor
Northern State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01685554
Brief Title
Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Valve Surgery
Official Title
Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Combined Valve Surgery: Single Center, Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northern State Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Diseases
Keywords
perfusion, cardiopulmonary bypass, hypothermia, cerebral oxygenation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
normothermic CPB
Arm Type
Active Comparator
Arm Description
cardiopulmonary bypass with maintenance of normal body temperature
Arm Title
hypothermic CPB
Arm Type
Active Comparator
Arm Description
cardiopulmonary bypass using mild hypothermia
Intervention Type
Device
Intervention Name(s)
hypothermic CPB
Intervention Description
maintenance of mild hypothermia during cardiopulmonary bypass
Intervention Type
Device
Intervention Name(s)
normothermic CPB
Intervention Description
maintenance of normal body temperature during cardiopulmonary bypass
Primary Outcome Measure Information:
Title
Cerebral oxygen saturation
Description
measurement of cerebral oxygen saturation during cardiopulmonary bypass and 24 hrs postoperatively
Time Frame
perioperatively
Secondary Outcome Measure Information:
Title
time until "fit for ICU discharge" fulfillment
Description
measurement of time to fulfillment of the "fit for discharge" criteria
Time Frame
5 days postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
requirement of surgical correction of two or more valves
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikhail Y Kirov, MD, PhD
Organizational Affiliation
Northern State Medical Univercity
Official's Role
Study Director
Facility Information:
Facility Name
Dep. of Anesthesiology, Northern SMU
City
Arkhangelsk
ZIP/Postal Code
163000
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
23407696
Citation
Lenkin AI, Zaharov VI, Lenkin PI, Smetkin AA, Bjertnaes LJ, Kirov MY. Normothermic cardiopulmonary bypass increases cerebral tissue oxygenation during combined valve surgery: a single-centre, randomized trial. Interact Cardiovasc Thorac Surg. 2013 May;16(5):595-601. doi: 10.1093/icvts/ivt016. Epub 2013 Feb 13.
Results Reference
derived
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Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Valve Surgery
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