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NCT Number: NCT01338961

Normothermia Versus Hypothermia for Valvular Surgery Patients

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.

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Key information

Conditions

Valvular Heart Disease Body Temperature Changes Cardiovascular Diseases Heart Diseases Heart Valve Diseases Hemorrhage Hypothermia Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

State Research Institute of Circulation Patholody

Novosibirsk, 630055, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypothermic CPB

Procedure

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 outcomes

  1. Cardiac Troponin I release

    Time frame: 48 hours

Secondary outcomes

  1. Need for Inotropic Support

    Time frame: First 48 postoperative hours

  2. Rate of Perioperative Myocardial Infarction

    Time frame: First 48 postoperative hours

  3. Rate of Type I and Type II neurological injury

    Time frame: 7 postoperative days

  4. Rate of Dialysis-dependent acute renal failure

    Time frame: 7 postoperative days

  5. Rate of infectious complications

    Time frame: 30 postoperative days

  6. Total units of Red Blood Cells transfused

    Time frame: 7 postoperative days

  7. Intensive Care Unit length of stay

    Time frame: 30 postoperative days

  8. Hospital length of stay

    Time frame: 30 postoperative days

  9. Rate of In-hospital mortality

    Time frame: 30 postoperative days

  10. NT-proBNP release

    Time frame: First 24 postoperative hours

  11. Bleeding from chest tubes

    Time frame: First 24 postoperative hours

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 20, 2011
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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