Normothermia Versus Hypothermia for Valvular Surgery Patients

Not Applicable

Completed

• Conditions: Valvular Heart Disease
• Interventions: Procedure: Hypothermic CPB

• Registration Number: NCT01338961
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-18
• Study First Submitted QC: 2011-04-19
• Study First Posted: 2011-04-20
• Primary Completion: 2013-01
• Study Completion: 2013-04
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-30
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypothermic CPB	Hypothermic CPB	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.

Primary Outcome Measures

Name	Time	Method
Cardiac Troponin I release	48 hours

Secondary Outcome Measures

Name	Time	Method
Need for Inotropic Support	First 48 postoperative hours
Rate of Perioperative Myocardial Infarction	First 48 postoperative hours
Rate of Type I and Type II neurological injury	7 postoperative days
Rate of Dialysis-dependent acute renal failure	7 postoperative days
Rate of infectious complications	30 postoperative days
Total units of Red Blood Cells transfused	7 postoperative days
Intensive Care Unit length of stay	30 postoperative days
Hospital length of stay	30 postoperative days
Rate of In-hospital mortality	30 postoperative days
NT-proBNP release	First 24 postoperative hours
Bleeding from chest tubes	First 24 postoperative hours

Trial Locations

Locations (1)

State Research Institute of Circulation Patholody; 🇷🇺 Novosibirsk, Russian Federation