- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01338961
Normothermia Versus Hypothermia for Valvular Surgery Patients
October 30, 2013 updated by: Efremov Sergey, Meshalkin Research Institute of Pathology of Circulation
Normothermia Versus Hypothermia for Patients With Valvular Heart Disease Operated Under Cardiopulmonary Bypass.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
140
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Novosibirsk, Russian Federation, 630055
- State Research Institute of Circulation Patholody
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cardiac Troponin I release
Time Frame: 48 hours
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intensive Care Unit length of stay
Time Frame: 30 postoperative days
|
30 postoperative days
|
Hospital length of stay
Time Frame: 30 postoperative days
|
30 postoperative days
|
Need for Inotropic Support
Time Frame: First 48 postoperative hours
|
First 48 postoperative hours
|
Rate of Perioperative Myocardial Infarction
Time Frame: First 48 postoperative hours
|
First 48 postoperative hours
|
Rate of Type I and Type II neurological injury
Time Frame: 7 postoperative days
|
7 postoperative days
|
Rate of Dialysis-dependent acute renal failure
Time Frame: 7 postoperative days
|
7 postoperative days
|
Rate of infectious complications
Time Frame: 30 postoperative days
|
30 postoperative days
|
Total units of Red Blood Cells transfused
Time Frame: 7 postoperative days
|
7 postoperative days
|
Rate of In-hospital mortality
Time Frame: 30 postoperative days
|
30 postoperative days
|
NT-proBNP release
Time Frame: First 24 postoperative hours
|
First 24 postoperative hours
|
Bleeding from chest tubes
Time Frame: First 24 postoperative hours
|
First 24 postoperative hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Vladimir V Lomivorotov, MD, PhD, Research Institute of Pathology of Circulation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
April 18, 2011
First Submitted That Met QC Criteria
April 19, 2011
First Posted (Estimate)
April 20, 2011
Study Record Updates
Last Update Posted (Estimate)
November 1, 2013
Last Update Submitted That Met QC Criteria
October 30, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HYPO-2010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Valvular Heart Disease
-
Dacima ConsultingTunisian Society of Cardiology and Cardiovascular SurgeryCompletedValvular Heart Disease | Valvular Stenosis | Valvular InsufficiencyTunisia
-
Yonsei UniversityCompletedMitral Valvular Heart Disease
-
University of PennsylvaniaCompleted
-
Assiut UniversityCompleted
-
Assiut UniversityActive, not recruitingValvular Heart Disease Stenosis and RegurgitationEgypt
-
Cliniques universitaires Saint-Luc- Université...RecruitingValvular Heart Disease Stenosis and Regurgitation (Diagnosis)Belgium
-
Assiut UniversityRecruitingValvular Heart Disease Stenosis and RegurgitationEgypt
-
Ruijin HospitalMed-X Research Institute, Shanghai Jiao Tong UniversityRecruitingPrimary Valvular Heart Disease With Comorbid Coronary Artery Disease | Planned to Undergo Elective On-pump Valve Surgery Due to Primary Mitral and/or Aortic Valvular Heart DiseaseChina
-
Cardenal Herrera UniversityUniversity of Valencia; Hospital de la RiberaNot yet recruitingExercise Based Prehabilitation in Valvular SurgerySpain
-
Yonsei UniversityCompletedValvular Heart Disease PatientsKorea, Republic of
Clinical Trials on Hypothermic CPB
-
Northern State Medical UniversityCompletedHeart Valve DiseasesRussian Federation
-
The Royal Wolverhampton Hospitals NHS TrustCompletedEnd Stage Renal Disease (ESRD) | Chronic Kidney Disease (CKD) | Acute Kidney Injury (AKI) | Estimated Glomerular Filtration Rate (eGFR) | Neutrophil Gelatinase-associated Lipocalin (NGAL) | Serum Creatinine (SCr) | Urine Creatinine (UCr) | Urine Albumin (UAlb)United Kingdom
-
Ospedale San RaffaeleUnknownMitral Regurgitation | Aortic RegurgitationItaly
-
University of BolognaUnknownLiver Diseases | Kidney DiseasesItaly
-
Hepatopancreatobiliary Surgery Institute of Gansu...CompletedHeart Valve DiseasesChina
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Completed
-
Sahlgrenska University Hospital, SwedenCompletedRenal Failure | Inflammatory Response | Hemolysis | Cardiopulmonary Bypass | Extracorporeal Circulation; Complications | Circulation Disorder | Renal Plasma Flow, EffectiveSweden
-
IRCCS San Raffaele RomaEttore Sansavini Health Science FoundationCompletedC.Surgical Procedure; CardiacItaly
-
Umeå UniversityMedtronicCompletedCardiopulmonary Bypass | Bleeding Disorder | Platelet Dysfunction Due to Drugs | Platelet DisorderSweden
-
Ottawa Heart Institute Research CorporationRecruitingThoracic Aortic DiseaseUnited States, Canada