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NCT01685554 Clinical Trial

Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Valve Surgery

Heart Valve Diseases Clinical Trial

Official title:
Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Combined Valve Surgery: Single Center, Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01685554
Other study ID # Norm-Arh-2012
Secondary ID
Status Completed
Phase N/A
First received September 4, 2012
Last updated October 17, 2012
Start date March 2010
Est. completion date December 2011

Study information
Verified date October 2012
Source Northern State Medical University
Contact n/a
Is FDA regulated No
Health authority Russia: Ministry of Health of the Russian Federation
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- requirement of surgical correction of two or more valves

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• hypothermic CPB
maintenance of mild hypothermia during cardiopulmonary bypass
• normothermic CPB
maintenance of normal body temperature during cardiopulmonary bypass

Locations
Country Name City State
Russian Federation Dep. of Anesthesiology, Northern SMU Arkhangelsk

Sponsors (1)
Lead Sponsor Collaborator
Northern State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cerebral oxygen saturation measurement of cerebral oxygen saturation during cardiopulmonary bypass and 24 hrs postoperatively perioperatively No
Secondary time until "fit for ICU discharge" fulfillment measurement of time to fulfillment of the "fit for discharge" criteria 5 days postoperatively No
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