Normothermia Versus Hypothermia for Valvular Surgery Patients

This study is currently recruiting participants.

Verified December 2012 by Meshalkin Research Institute of Pathology of Circulation

Sponsor:

Information provided by (Responsible Party):

Efremov Sergey, Meshalkin Research Institute of Pathology of Circulation

ClinicalTrials.gov Identifier:

NCT01338961

First received: April 18, 2011

Last updated: December 19, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 18, 2011

Last Updated Date

December 19, 2012

Start Date ^ICMJE

April 2011

Estimated Primary Completion Date

May 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cardiac Troponin I release [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01338961 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Need for Inotropic Support [ Time Frame: First 48 postoperative hours ] [ Designated as safety issue: Yes ]
Rate of Perioperative Myocardial Infarction [ Time Frame: First 48 postoperative hours ] [ Designated as safety issue: Yes ]
Rate of Type I and Type II neurological injury [ Time Frame: 7 postoperative days ] [ Designated as safety issue: Yes ]
Rate of Dialysis-dependent acute renal failure [ Time Frame: 7 postoperative days ] [ Designated as safety issue: Yes ]
Rate of infectious complications [ Time Frame: 30 postoperative days ] [ Designated as safety issue: Yes ]
Total units of RBCs transfused [ Time Frame: 7 postoperative days ] [ Designated as safety issue: Yes ]
Intensive Care Unit length of stay [ Time Frame: 30 postoperative days ] [ Designated as safety issue: Yes ]
Hospital length of stay [ Time Frame: 30 postoperative days ] [ Designated as safety issue: Yes ]
Rate of In-hospital mortality [ Time Frame: 30 postoperative days ] [ Designated as safety issue: Yes ]
NT-proBNP release [ Time Frame: First 24 postoperative hours ] [ Designated as safety issue: Yes ]
Bleeding from chest tubes [ Time Frame: First 24 postoperative hours ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Normothermia Versus Hypothermia for Valvular Surgery Patients

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Valvular Heart Disease

Intervention ^ICMJE

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

Study Arm (s)

No Intervention: Normothermic CPB
Standard management. Patients will be kept at normothermia throughout the procedure (>36oC).
Active Comparator: 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.

Intervention: Procedure: Hypothermic CPB

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

500

Estimated Completion Date

June 2015

Estimated Primary Completion Date

May 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Vladimir V Lomivorotov, MD, PhD	+73832924103	v.lomivorotov@gmail.com
Contact: Vladimir A Shmirev, MD, PhD	+73833325182	shmyrevv@gmail.com

Location Countries ^ICMJE

Russian Federation

Administrative Information

NCT Number ^ICMJE

NCT01338961

Other Study ID Numbers ^ICMJE

HYPO-2010

Has Data Monitoring Committee

Responsible Party

Efremov Sergey, Meshalkin Research Institute of Pathology of Circulation

Study Sponsor ^ICMJE

Meshalkin Research Institute of Pathology of Circulation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Vladimir V Lomivorotov, MD, PhD

Research Institute of Pathology of Circulation

Information Provided By

Meshalkin Research Institute of Pathology of Circulation

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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