Valvular Heart DiseaseNCT01276444
Comparison of Goal-directed Algorithms of Hemodynamic Therapy After Combined Valve Repair
A study testing Swan-Ganz catheter and transpulmonary thermodilution + central venous saturation in people with Valvular Heart Disease, run by Northern State Medical University at 1 site in Russia.
Trial summary
Valvular repair and repair surgery is rapidly progressing yet rather challenging aspect of current cardiosurgical practice. Several approaches were introduced into the clinical practice to alleviate systemic inflammatory response induced by cardiopulmonary bypass and organ-specific injury including meticulous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Valvular Heart Disease
- What is being tested?
- Swan-Ganz catheter and transpulmonary thermodilution + central venous saturation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2008to Sep 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Two valve repair / replacements
- Age above 18
- Informed consent
Who cannot join
- pulmonary hypertension
- insulin-dependent diabetes mellitus
- severe atherosclerosis of femoral arteries
- severe respiratory failure
- pregnancy
Trial locations and contacts
1 site in 1 country.
Russia1 site
City hospital # 1 / Northern State Medical University,
Arkhangelsk, 163000
About this study
Official title: Comparison of Goal-directed Algorithms of Hemodynamic Therapy After Combined Valve Repair: a Randomized Clinical Trial
Valvular repair and repair surgery is rapidly progressing yet rather challenging aspect of current cardiosurgical practice.
Several approaches were introduced into the clinical practice to alleviate systemic inflammatory response induced by cardiopulmonary bypass and organ-specific injury including meticulous haemodynamic monitoring, pharmacological heart preconditioning, systemic use of anti-inflammatory agents, prevention of coagulopathy, and induced topical and systemic hypothermia. An in-depth monitoring of haemodynamics, oxygen transport, and vascular permeability is of a great clinical value to control the efficacy of these approaches.
Therefore, the aim of this study was to compare two algorithms of goal-directed therapy aimed to achieve a postoperative haemodynamic optimization in combined valve repair surgery.
Read the detailed description
Forty-three adult patients scheduled for elective two valve replacement/repair were enrolled into randomised single-centre study. All interventions were performed in cardiosurgical department of City hospital #1 (Arkhangelsk, Russian Federation) by the same surgical team. Three patients were excluded from the analysis; two - due to protocol violation and one - due to inadequate surgical correction diagnosed by intraoperative transoesophageal echocardiography.
Day before surgery patients were asked for informed consent and randomized in two groups. In the first group postoperative haemodynamic optimization was targeted on parameters provided by pulmonary artery catheter (the PAC-group, n = 20): pulmonary arterial occlusion pressure, cardiac index (LifeScope monitor, Nihon Kohden, Japan) and hemoglobin blood level. In the second group haemodynamics was managed using parameters given by transpulmonary thermodilution (the COMPLEX-group), that included cardiac index, global end-diastolic volume index, extravascular lung water index, continuous central venous oxygen saturation, and oxygen delivery index as measured with PiCCO2 monitor (Pulsion Medical Systems, Munich, Germany. In addition, mean arterial pressure, heart rate, and hemoglobin concentration were included into both PAC- and PiCCO2-driven protocols.
- Conditions
- Valvular Heart Disease
- Being tested
- Swan-Ganz catheter, transpulmonary thermodilution + central venous saturation
- Keywords
- valve repair, postoperative period, goal-directed therapy, pulmonary artery catheter, transpulmonary thermodilution, central venous oxygen saturation
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swan-Ganz catheterDevice
Also called Not actual
the data s=derived from PAC included pulmonary artery occlusion pressure etc
transpulmonary thermodilution + central venous saturationDevice
Also called Non actual
Described in details above
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary artery catheter (PAC) | Active comparator | PAC was used to guide hemodynamic therapy after combined valve repair Receives: Device: Swan-Ganz catheter |
| COMPLEX | Active comparator | An combination of transpulmonary thermodilution and continuous monitoring of central venous saturation was used to guide hemodynamic therapy after combined valve repair surgery. Receives: Device: transpulmonary thermodilution + central venous saturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality rate at Day 28
Measured: Day 28
Secondary outcomes (3)
Fit for discharge
Formal 'fit for discharge from ICU' criteria
Measured: non actual
Vasoactive support
Duration of vasopressor and or inotrope support
Measured: 7 days
Duration of respiratory support
The total duration of the respiratory support
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startJan 2008
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern State Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso
- Investigators
- Mikhail Y. Kirov, MD, PhD, Principal investigator, Northern State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276444
- Sponsor's protocol ID
- SCVO2-2008
- Status last verified
- Jan 2011
- First submitted
- 4 Jan 2011
- Last updated
- 13 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Goal-directed Algorithms of Hemodynamic Therapy After Combined Valve Repair: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01276444
- Acronym / sponsor ID
- SCVO2-2008
- Conditions
- Valvular Heart Disease
- Keywords
- valve repair, postoperative period, goal-directed therapy, pulmonary artery catheter, transpulmonary thermodilution, central venous oxygen saturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Northern State Medical UniversityUniversity, hospital or other
- Collaborators
- University of Tromso
- Study start
- Jan 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 13 Jan 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.
Valvular repair and repair surgery is rapidly progressing yet rather challenging aspect of current cardiosurgical practice.
Several approaches were introduced into the clinical practice to alleviate systemic inflammatory response induced by cardiopulmonary bypass and organ-specific injury including meticulous haemodynamic monitoring, pharmacological heart preconditioning, systemic use of anti-inflammatory agents, prevention of coagulopathy, and induced topical and systemic hypothermia. An in-depth monitoring of haemodynamics, oxygen transport, and vascular permeability is of a great clinical value to control the efficacy of these approaches.
Therefore, the aim of this study was to compare two algorithms of goal-directed therapy aimed to achieve a postoperative haemodynamic optimization in combined valve repair surgery.
Detailed description
Forty-three adult patients scheduled for elective two valve replacement/repair were enrolled into randomised single-centre study. All interventions were performed in cardiosurgical department of City hospital #1 (Arkhangelsk, Russian Federation) by the same surgical team. Three patients were excluded from the analysis; two - due to protocol violation and one - due to inadequate surgical correction diagnosed by intraoperative transoesophageal echocardiography.
Day before surgery patients were asked for informed consent and randomized in two groups. In the first group postoperative haemodynamic optimization was targeted on parameters provided by pulmonary artery catheter (the PAC-group, n = 20): pulmonary arterial occlusion pressure, cardiac index (LifeScope monitor, Nihon Kohden, Japan) and hemoglobin blood level. In the second group haemodynamics was managed using parameters given by transpulmonary thermodilution (the COMPLEX-group), that included cardiac index, global end-diastolic volume index, extravascular lung water index, continuous central venous oxygen saturation, and oxygen delivery index as measured with PiCCO2 monitor (Pulsion Medical Systems, Munich, Germany. In addition, mean arterial pressure, heart rate, and hemoglobin concentration were included into both PAC- and PiCCO2-driven protocols.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary artery catheter (PAC) | Active comparator | Device: Swan-Ganz catheterPAC was used to guide hemodynamic therapy after combined valve repair |
| COMPLEX | Active comparator | Device: transpulmonary thermodilution + central venous saturationAn combination of transpulmonary thermodilution and continuous monitoring of central venous saturation was used to guide hemodynamic therapy after combined valve repair surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Two valve repair / replacements
- Age above 18
- Informed consent
Key exclusion criteria (5 listed)
- pulmonary hypertension
- insulin-dependent diabetes mellitus
- severe atherosclerosis of femoral arteries
- severe respiratory failure
- pregnancy
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 |
|---|---|---|
| Swan-Ganz catheterAlso: Not actualthe data s=derived from PAC included pulmonary artery occlusion pressure etc | Device | Pulmonary artery catheter (PAC) |
| transpulmonary thermodilution + central venous saturationAlso: Non actualDescribed in details above | Device | COMPLEX |
Primary outcome
Mortality
Time frame: Day 28
Mortality rate at Day 28
3 secondary outcomes
Fit for discharge
Time frame: non actual
Vasoactive support
Time frame: 7 days
Duration of respiratory support
Time frame: Day 7
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 13 Jan 2011.
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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 principal investigator
Northern State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swan-Ganz catheter and transpulmonary thermodilution + central venous saturation in people with Valvular Heart Disease, 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 3 inclusion and 5 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 13 Jan 2011. 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?
Mortality (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2011.