Clinical trial NCT01338961: Normothermia Versus Hypothermia for Valvular Surgery Patients
Official title: Normothermia Versus Hypothermia for Patients With Valvular Heart Disease Operated Under Cardiopulmonary Bypass.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Valvular Heart Disease
Keywords: Cardiopulmonary Bypass
Hypothermia
Normothermia
Troponin I
Bleeding
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2011-04-20
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cardiac Troponin I release
timeFrame: 48 hours
Secondary outcomes:
measure: Need for Inotropic Support
timeFrame: First 48 postoperative hours
measure: Rate of Perioperative Myocardial Infarction
timeFrame: First 48 postoperative hours
measure: Rate of Type I and Type II neurological injury
timeFrame: 7 postoperative days
measure: Rate of Dialysis-dependent acute renal failure
timeFrame: 7 postoperative days
measure: Rate of infectious complications
timeFrame: 30 postoperative days
measure: Total units of Red Blood Cells transfused
timeFrame: 7 postoperative days
measure: Intensive Care Unit length of stay
timeFrame: 30 postoperative days
measure: Hospital length of stay
timeFrame: 30 postoperative days
measure: Rate of In-hospital mortality
timeFrame: 30 postoperative days
measure: NT-proBNP release
timeFrame: First 24 postoperative hours
measure: Bleeding from chest tubes
timeFrame: First 24 postoperative hours
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Patholody
Study officials:
affiliation: Research Institute of Pathology of Circulation
name: Vladimir V Lomivorotov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. 2014 Apr;28(2):295-300. doi: 10.1053/j.jvca.2013.03.009. Epub 2013 Aug 17.