Heart Valve DiseasesNCT01685554
Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Valve Surgery
A study testing hypothermic CPB and normothermic CPB in people with Heart Valve Diseases, run by Northern State Medical University at 1 site in Russia.
Trial summary
The aim of our study was to evaluate the effect of different temperature regimens of cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during surgical correction of acquired heart diseases. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Valve Diseases
- What is being tested?
- hypothermic CPB and normothermic CPB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- Mar 2010to Dec 2011
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- requirement of surgical correction of two or more valves
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Combined Valve Surgery: Single Center, Randomized Trial
The aim of our study was to evaluate the effect of different temperature regimens of cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during surgical correction of acquired heart diseases.
Read the detailed description
Our aim was to evaluate the effect of hypothermic and normothermic regimens of cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during valve surgery
- Conditions
- Heart Valve Diseases
- Being tested
- hypothermic CPB, normothermic CPB
- Keywords
- perfusion, cardiopulmonary bypass, hypothermia, cerebral oxygenation
- Medical subject headings
- Heart Valve Diseases, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypothermic CPBDevice
maintenance of mild hypothermia during cardiopulmonary bypass
normothermic CPBDevice
maintenance of normal body temperature during cardiopulmonary bypass
| Study group | Role | What they receive |
|---|---|---|
| normothermic CPB | Active comparator | cardiopulmonary bypass with maintenance of normal body temperature Receives: Device: normothermic CPB |
| hypothermic CPB | Active comparator | cardiopulmonary bypass using mild hypothermia Receives: Device: hypothermic CPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral oxygen saturation
measurement of cerebral oxygen saturation during cardiopulmonary bypass and 24 hrs postoperatively
Measured: perioperatively
Secondary outcomes (1)
time until "fit for ICU discharge" fulfillment
measurement of time to fulfillment of the "fit for discharge" criteria
Measured: 5 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startMar 2010
- Primary completionDec 2011
- Study completionDec 2011
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 Heart Valve DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mikhail Y Kirov, MD, PhD, Study director, Northern State Medical Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685554
- Sponsor's protocol ID
- Norm-Arh-2012
- Status last verified
- Oct 2012
- First submitted
- 4 Sep 2012
- Last updated
- 18 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lenkin AI, Zaharov VI, Lenkin PI, Smetkin AA, Bjertnaes LJ, Kirov MY. Normothermic cardiopulmonary bypass increases cerebral tissue oxygenation during combined valve surgery: a single-centre, randomized trial. Interact Cardiovasc Thorac Surg. 2013 May;16(5):595-601. doi: 10.1093/icvts/ivt016. Epub 2013 Feb 13.
PubMed 23407696
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Combined Valve Surgery: Single Center, Randomized Trial
- ClinicalTrials.gov ID
- NCT01685554
- Acronym / sponsor ID
- Norm-Arh-2012
- Conditions
- Heart Valve Diseases
- Keywords
- perfusion, cardiopulmonary bypass, hypothermia, cerebral oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northern State Medical UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Sep 2012 (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.
The aim of our study was to evaluate the effect of different temperature regimens of cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during surgical correction of acquired heart diseases.
Detailed description
Our aim was to evaluate the effect of hypothermic and normothermic regimens of cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during valve surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normothermic CPB | Active comparator | Device: normothermic CPBcardiopulmonary bypass with maintenance of normal body temperature |
| hypothermic CPB | Active comparator | Device: hypothermic CPBcardiopulmonary bypass using mild hypothermia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- requirement of surgical correction of two or more valves
Key exclusion criteria (0 listed)
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 CPBmaintenance of mild hypothermia during cardiopulmonary bypass | Device | hypothermic CPB |
| normothermic CPBmaintenance of normal body temperature during cardiopulmonary bypass | Device | normothermic CPB |
Primary outcome
Cerebral oxygen saturation
Time frame: perioperatively
measurement of cerebral oxygen saturation during cardiopulmonary bypass and 24 hrs postoperatively
1 secondary outcome
time until "fit for ICU discharge" fulfillment
Time frame: 5 days postoperatively
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 18 Oct 2012.
- Derived from this study: PubMed 23407696Lenkin AI, Zaharov VI, Lenkin PI, Smetkin AA, Bjertnaes LJ, Kirov MY. Normothermic cardiopulmonary bypass increases cerebral tissue oxygenation during combined valve surgery: a single-centre, randomized trial. Interact Cardiovasc Thorac Surg. 2013 May;16(5):595-601. doi: 10.1093/icvts/ivt016. Epub 2013 Feb 13.
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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.
Mikhail Y Kirov, MD, PhD study director
Northern State Medical Univercity
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 and normothermic CPB in people with Heart Valve Diseases, run by Northern State Medical University 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 1 inclusion and 0 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 18 Oct 2012. 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?
Cerebral oxygen saturation (time frame: perioperatively). 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 NCT01685554, 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 18 Oct 2012.