Normothermia Versus Hypothermia for Valvular Surgery Patients

This study has been completed.
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: October 30, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Valvular Heart Disease
Procedure: Hypothermic CPB

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Normothermia Versus Hypothermia for Patients With Valvular Heart Disease Operated Under Cardiopulmonary Bypass.

Resource links provided by NLM:


Further study details as provided by Meshalkin Research Institute of Pathology of Circulation:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 140
Study Start Date: April 2011
Study Completion Date: April 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01338961

Locations
Russian Federation
State Research Institute of Circulation Patholody
Novosibirsk, Russian Federation, 630055
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
Principal Investigator: Vladimir V Lomivorotov, MD, PhD Research Institute of Pathology of Circulation
  More Information

Publications:
Responsible Party: Efremov Sergey, Anesthesist, Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT01338961     History of Changes
Other Study ID Numbers: HYPO-2010
Study First Received: April 18, 2011
Last Updated: October 30, 2013
Health Authority: Russia: Ethics Committee

Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
Cardiopulmonary Bypass
Hypothermia
Normothermia
Troponin I
Bleeding

Additional relevant MeSH terms:
Heart Diseases
Heart Valve Diseases
Hypothermia
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014