Valvular Heart DiseaseNCT01338961
Normothermia Versus Hypothermia for Valvular Surgery Patients
A study testing Hypothermic CPB in people with Valvular Heart Disease, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Valvular Heart Disease
- What is being tested?
- Hypothermic CPB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteRussia
- Study dates
- Apr 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Isolated heart valve surgery
- Heart valve surgery plus CABG
- Age 20-80
Who cannot join
- 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
Show all 9Show fewer
- Planed deep hypothermic circulatory arrest
- History of acute myocardial infarction in the last 3 month
- Preoperative core temperature >37oC
Trial locations and contacts
1 site in 1 country.
Russia1 site
State Research Institute of Circulation Patholody
Novosibirsk, 630055
About this study
Official title: 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.
- Conditions
- Valvular Heart Disease
- Being tested
- Hypothermic CPB
- Keywords
- Cardiopulmonary Bypass, Hypothermia, Normothermia, Troponin I, Bleeding
- Medical subject headings
- Heart Valve Diseases, Hypothermia, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypothermic CPBProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Normothermic CPB | No intervention | Standard management. Patients will be kept at normothermia throughout the procedure (>36oC). |
| Hypothermic CPB | Active comparator | 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. Receives: Procedure: Hypothermic CPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Troponin I release
Measured: 48 hours
Secondary outcomes (11)
Need for Inotropic Support
Measured: First 48 postoperative hours
Rate of Perioperative Myocardial Infarction
Measured: First 48 postoperative hours
Rate of Type I and Type II neurological injury
Measured: 7 postoperative days
Rate of Dialysis-dependent acute renal failure
Measured: 7 postoperative days
Rate of infectious complications
Measured: 30 postoperative days
Total units of Red Blood Cells transfused
Measured: 7 postoperative days
Intensive Care Unit length of stay
Measured: 30 postoperative days
Hospital length of stay
Measured: 30 postoperative days
Rate of In-hospital mortality
Measured: 30 postoperative days
NT-proBNP release
Measured: First 24 postoperative hours
Bleeding from chest tubes
Measured: First 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Efremov Sergey, Meshalkin Research Institute of Pathology of Circulation
- Investigators
- Vladimir V Lomivorotov, MD, PhD, Principal investigator, Research Institute of Pathology of Circulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01338961
- Sponsor's protocol ID
- HYPO-2010
- Status last verified
- Oct 2013
- First submitted
- 18 Apr 2011
- Last updated
- 1 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23962460
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normothermia Versus Hypothermia for Patients With Valvular Heart Disease Operated Under Cardiopulmonary Bypass.
- ClinicalTrials.gov ID
- NCT01338961
- Acronym / sponsor ID
- HYPO-2010
- Conditions
- Valvular Heart Disease
- Keywords
- Cardiopulmonary Bypass, Hypothermia, Normothermia, Troponin I, Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Apr 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 20 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normothermic CPB | No intervention | –Standard management. Patients will be kept at normothermia throughout the procedure (>36oC). |
| Hypothermic CPB | Active comparator | Procedure: Hypothermic CPBPatients 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Isolated heart valve surgery
- Heart valve surgery plus CABG
- Age 20-80
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypothermic CPBPatients 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 or surgery | Hypothermic CPB |
Primary outcome
Cardiac Troponin I release
Time frame: 48 hours
11 secondary outcomes
Need for Inotropic Support
Time frame: First 48 postoperative hours
Rate of Perioperative Myocardial Infarction
Time frame: First 48 postoperative hours
Rate of Type I and Type II neurological injury
Time frame: 7 postoperative days
Rate of Dialysis-dependent acute renal failure
Time frame: 7 postoperative days
Rate of infectious complications
Time frame: 30 postoperative days
Total units of Red Blood Cells transfused
Time frame: 7 postoperative days
Intensive Care Unit length of stay
Time frame: 30 postoperative days
Hospital length of stay
Time frame: 30 postoperative days
Rate of In-hospital mortality
Time frame: 30 postoperative days
NT-proBNP release
Time frame: First 24 postoperative hours
Bleeding from chest tubes
Time frame: First 24 postoperative hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
- Results publication: PubMed 23962460Lomivorotov 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir V Lomivorotov, MD, PhD principal investigator
Research Institute of Pathology of Circulation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypothermic CPB in people with Valvular Heart Disease, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Troponin I release (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01338961, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2013.