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Normothermia Versus Hypothermia for Valvular Surgery Patients

Primary Purpose

Valvular Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Hypothermic CPB
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Valvular Heart Disease focused on measuring Cardiopulmonary Bypass, Hypothermia, Normothermia, Troponin I, Bleeding

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • State Research Institute of Circulation Patholody

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Normothermic CPB

Hypothermic CPB

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Cardiac Troponin I release

Secondary Outcome Measures

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

Full Information

First Posted
April 18, 2011
Last Updated
October 30, 2013
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT01338961
Brief Title
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

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valvular Heart Disease
Keywords
Cardiopulmonary Bypass, Hypothermia, Normothermia, Troponin I, Bleeding

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normothermic CPB
Arm Type
No Intervention
Arm Description
Standard management. Patients will be kept at normothermia throughout the procedure (>36oC).
Arm Title
Hypothermic CPB
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Hypothermic CPB
Intervention 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
Primary Outcome Measure Information:
Title
Cardiac Troponin I release
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Need for Inotropic Support
Time Frame
First 48 postoperative hours
Title
Rate of Perioperative Myocardial Infarction
Time Frame
First 48 postoperative hours
Title
Rate of Type I and Type II neurological injury
Time Frame
7 postoperative days
Title
Rate of Dialysis-dependent acute renal failure
Time Frame
7 postoperative days
Title
Rate of infectious complications
Time Frame
30 postoperative days
Title
Total units of Red Blood Cells transfused
Time Frame
7 postoperative days
Title
Intensive Care Unit length of stay
Time Frame
30 postoperative days
Title
Hospital length of stay
Time Frame
30 postoperative days
Title
Rate of In-hospital mortality
Time Frame
30 postoperative days
Title
NT-proBNP release
Time Frame
First 24 postoperative hours
Title
Bleeding from chest tubes
Time Frame
First 24 postoperative hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir V Lomivorotov, MD, PhD
Organizational Affiliation
Research Institute of Pathology of Circulation
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Research Institute of Circulation Patholody
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
23962460
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.
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Normothermia Versus Hypothermia for Valvular Surgery Patients

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