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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goal directed therapy | Experimental | Based on transpulmonary thermodilution, hemodynamic management will be implemented to achieve predefined goals |
|
| Control | Active Comparator | Conventional therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goal directed therapy | Procedure | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Major complications | Composite of all-cause mortality, extracorporal membrane oxygenation use, cardiac arrest, renal impairment (pRIFLE score of "injury" or higher), sepsis | Through study completion, an average of 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vladimir Lomivorotov, PhD | Contact | +79139164103 | vv_lomivorotov@meshalkin.ru | |
| Dmitry Ponomarev, PhD | Contact | +79232339205 | d_ponomarev@meshalkin.ru |
| Name | Affiliation | Role |
|---|---|---|
| Vladimir Lomivorotov, PhD | Novosibirsk Research Institute of Cirulation Pathology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novosibirsk Research Institute of Circulation Pathology | Recruiting | Novosibirsk | 630055 | Russia |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D000074388 | Early Goal-Directed Therapy |
| ID | Term |
|---|---|
| D003422 | Critical Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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|
| Control | Other |
|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |