Normothermia Versus Hypothermia for Valvular Surgery Patients

Valvular Heart Disease Clinical Trial

Official title:

Normothermia Versus Hypothermia for Patients With Valvular Heart Disease Operated Under Cardiopulmonary Bypass.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338961
• Other study ID #: HYPO-2010
• Status: Completed
• Phase: N/A
• First received: April 18, 2011
• Last updated: October 30, 2013
• Start date: April 2011
• Est. completion date: April 2013

Study information

• Verified date: October 2013
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Hypothermia
• Valvular Heart Disease

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Russian Federation	State Research Institute of Circulation Patholody	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

Lomivorotov VV, Shmirev VA, Efremov SM, Ponomarev DN, Moroz GB, Shahin DG, Kornilov IA, Shilova AN, Lomivorotov VN, Karaskov AM. Hypothermic versus normothermic cardiopulmonary bypass in patients with valvular heart disease. J Cardiothorac Vasc Anesth. 20 — View Citation

Outcome

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