Cardiac SurgeryPhase 3NCT02617602
Goal Directed Hemodynamic Management of Acute Heart Failure After Cardiac Surgery in Children
A Phase 3 study testing Goal directed therapy in people with Cardiac Surgery, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
Goal directed therapy (GDT) utilises various monitoring techniques to assess cardiovascular performance and allows for timely interventions based on predetermined algorithms. The aim of this prospective randomised study is to evaluate the effect of GDT on major complications in children undergoing radical correction… Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Goal directed therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- Dec 2015to Dec 2017
- Phase
- Phase 3
- 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 Up to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- informed written consent signed by legal representative (parent or guardian)
- radical correction of congenital heart defect(s)
- use of cardiopulmonary bypass
- vasoactive-inotropic Score of 10 or greater during first 24 hours after surgery.
Who cannot join
- confirmed intranatal infection;
- gestational age < 37 weeks;
- inotropic support prior to surgery;
- acute renal or hepatic failure prior to surgery;
- participation in conflicting randomised controlled studies.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Novosibirsk Research Institute of Circulation Pathology
Novosibirsk, 630055
Dmitry Ponomarev, PhD, +79232339205, d_ponomarev@meshalkin.ru
About this study
Official title: Goal Directed Hemodynamic Management of Acute Heart Failure After Cardiac Surgery in Children: a Prospective Randomised Trial
Goal directed therapy (GDT) utilises various monitoring techniques to assess cardiovascular performance and allows for timely interventions based on predetermined algorithms. The aim of this prospective randomised study is to evaluate the effect of GDT on major complications in children undergoing radical correction of congenital heart defects, complicated by acute heart failure. Goal directed therapy will be implemented with the aid of transpulmonary thermodilution and based on predetermined algorithms.
- Conditions
- Cardiac Surgery
- Being tested
- Goal directed therapy, Control
- Keywords
- Congenital heart defect, Cardiopulmonary bypass, Goal directed therapy, Acute heart failure
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal directed therapyProcedure or surgery
Based on transpulmonary thermodilution data, the following interventions will be implemented:
Global end diastolic volume (GEDV) ≤ 430 ml/m2 and extravascular water index (EVWI) ≤ 10 ml/kg: fluid load; GEDV ≥ 550 ml/m2 and EVWI ≥ 10 ml/kg: furosemide;
cardiac index (CI) ≤ 2 l/min/m2 - inotropic support:
- decreased heart rate (HR): dobutamine, dopamine;
- normal or increased HR: epinephrine, norepinephrine; CI ≥ 2 l/min/m2 and normovolemia: phenylephrine.
ControlOther
| Study group | Role | What they receive |
|---|---|---|
| Goal directed therapy | Experimental | Based on transpulmonary thermodilution, hemodynamic management will be implemented to achieve predefined goals Receives: Procedure: Goal directed therapy |
| Control | Active comparator | Conventional therapy Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major complications
Composite of all-cause mortality, extracorporal membrane oxygenation use, cardiac arrest, renal impairment (pRIFLE score of "injury" or higher), sepsis
Measured: Through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Vladimir Lomivorotov, PhD, Principal investigator, Novosibirsk Research Institute of Cirulation Pathology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617602
- Sponsor's protocol ID
- GDT1.0
- Status last verified
- Dec 2015
- First submitted
- 23 Nov 2015
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal Directed Hemodynamic Management of Acute Heart Failure After Cardiac Surgery in Children: a Prospective Randomised Trial
- ClinicalTrials.gov ID
- NCT02617602
- Acronym / sponsor ID
- GDT1.0
- Conditions
- Cardiac Surgery
- Keywords
- Congenital heart defect, Cardiopulmonary bypass, Goal directed therapy, Acute heart failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Dec 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 1 Dec 2015 (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.
Goal directed therapy (GDT) utilises various monitoring techniques to assess cardiovascular performance and allows for timely interventions based on predetermined algorithms. The aim of this prospective randomised study is to evaluate the effect of GDT on major complications in children undergoing radical correction of congenital heart defects, complicated by acute heart failure. Goal directed therapy will be implemented with the aid of transpulmonary thermodilution and based on predetermined algorithms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal directed therapy | Experimental | Procedure: Goal directed therapyBased on transpulmonary thermodilution, hemodynamic management will be implemented to achieve predefined goals |
| Control | Active comparator | Other: ControlConventional therapy |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- informed written consent signed by legal representative (parent or guardian)
- radical correction of congenital heart defect(s)
- use of cardiopulmonary bypass
- vasoactive-inotropic Score of 10 or greater during first 24 hours after surgery.
Key exclusion criteria (5 listed)
- confirmed intranatal infection;
- gestational age < 37 weeks;
- inotropic support prior to surgery;
- acute renal or hepatic failure prior to surgery;
- participation in conflicting randomised controlled studies.
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 |
|---|---|---|
| Goal directed therapyBased on transpulmonary thermodilution data, the following interventions will be implemented: Global end diastolic volume (GEDV) ≤ 430 ml/m2 and extravascular water index (EVWI) ≤ 10 ml/kg: fluid load; GEDV ≥ 550 ml/m2 and EVWI ≥ 10 ml/kg: furosemide; cardiac index (CI) ≤ 2 l/min/m2 - inotropic support: * decreased heart rate (HR): dobutamine, dopamine; * normal or increased HR: epinephrine, norepinephrine; CI ≥ 2 l/min/m2 and normovolemia: phenylephrine. | Procedure or surgery | Goal directed therapy |
| Control | Other | Control |
Primary outcome
Major complications
Time frame: Through study completion, an average of 30 days
Composite of all-cause mortality, extracorporal membrane oxygenation use, cardiac arrest, renal impairment (pRIFLE score of "injury" or higher), sepsis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
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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 Lomivorotov, PhD principal investigator
Novosibirsk Research Institute of Cirulation Pathology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Goal directed therapy in people with Cardiac Surgery, 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 4 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: status not confirmed, as of the sponsor's last update on 18 Dec 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vladimir Lomivorotov, PhD (+79139164103, vv_lomivorotov@meshalkin.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major complications (time frame: Through study completion, an average of 30 days). 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 18 Dec 2015.