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Completed

NCT Number: NCT01685554

Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Valve Surgery

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.

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Key information

Conditions

Heart Valve Diseases Body Temperature Changes Cardiovascular Diseases Heart Diseases Hypothermia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dep. of Anesthesiology, Northern SMU

Arkhangelsk, 163000, Russia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • requirement of surgical correction of two or more valves

Treatment and study plan

hypothermic CPB

Device

maintenance of mild hypothermia during cardiopulmonary bypass

normothermic CPB

Device

maintenance of normal body temperature during cardiopulmonary bypass

Primary outcomes

  1. Cerebral oxygen saturation

    Time frame: perioperatively

    measurement of cerebral oxygen saturation during cardiopulmonary bypass and 24 hrs postoperatively

Secondary outcomes

  1. time until "fit for ICU discharge" fulfillment

    Time frame: 5 days postoperatively

    measurement of time to fulfillment of the "fit for discharge" criteria

Sponsors and collaborators

Lead sponsor

Northern State Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 14, 2012
Registry last updated
Oct 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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