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Normothermia Versus Hypothermia for Valvular Surgery Patients

NCT ID: NCT01338961

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-04-30

Brief Summary

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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

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Conditions

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Valvular Heart Disease

Keywords

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Cardiopulmonary Bypass Hypothermia Normothermia Troponin I Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Normothermic CPB

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Hypothermic CPB

Intervention Type 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

Interventions

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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 Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Efremov Sergey

Anesthesist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vladimir V Lomivorotov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Institute of Pathology of Circulation

Locations

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State Research Institute of Circulation Patholody

Novosibirsk, , Russia

Site Status

Countries

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Russia

References

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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.

Reference Type RESULT
PMID: 23962460 (View on PubMed)

Other Identifiers

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HYPO-2010

Identifier Type: -

Identifier Source: org_study_id