Normothermia Versus Hypothermia for Valvular Surgery Patients

Meshalkin Research Institute of Pathology of Circulation

Status: Completed

Conditions: Valvular Heart Disease

Treatments: Procedure: Hypothermic CPB

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01338961

HYPO-2010

Details and patient eligibility

About

Cardiopulmonary bypass (CPB) has been used successfully for cardiac surgery for over half a century. Hypothermia became a ubiquitous practice for adult patients undergoing CPB. To date, most studies have been conducted in coronary artery bypass graft (CABG) patients with conflicting results. Current evidence does not support one temperature management strategy for all patients. The purpose of this study is to compare the efficiency and safety of normothermic versus hypothermic CPB in valvular surgery patients.

Enrollment: 140 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Isolated heart valve surgery
• Heart valve surgery plus CABG
• Age 20-80

Exclusion criteria

• urgent operation
• Left ventricle ejection fraction < 35%
• Decompensated congestive heart failure
• Chronic renal failure (glomerular filtration rate < 60 ml/min)
• Severe hepatic and pulmonary disease
• Bleeding diathesis or history of coagulopathy
• Planed deep hypothermic circulatory arrest
• History of acute myocardial infarction in the last 3 month
• Preoperative core temperature >37oC

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Normothermic CPB

No Intervention group

Description:

Standard management. Patients will be kept at normothermia throughout the procedure (\>36oC).

Hypothermic CPB

Active Comparator group

Description:

Patients will be cooled to 31-32oC (nasopharyngeal) after the beginning of CPB. Rewarming will begin 10-15 min before release of aortic cross-clamp. The gradient between heat-exchanger and nasopharynx during rewarming will be maintained at 3oC. The rewarming will be stopped at 36,5oC.

Treatment:

Procedure: Hypothermic CPB