Comparison of Goal-directed Algorithms of Hemodynamic Therapy After Combined Valve Repair

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Goal-directed Algorithms of Hemodynamic Therapy After Combined Valve Repair: a Randomized Clinical Trial

Conditions
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Valvular Heart Disease

Intervention / Treatment
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* Device: Swan-Ganz catheter
* Device: transpulmonary thermodilution + central venous saturation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Two valve repair / replacements Age above 18 Informed consent Exclusion Criteria: pulmonary hypertension insulin-dependent diabetes mellitus severe atherosclerosis of femoral arteries severe respiratory failure pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulmonary artery catheter (PAC)<br>PAC was used to guide hemodynamic therapy after combined valve repair | Device: Swan-Ganz catheter<br>* the data s=derived from PAC included pulmonary artery occlusion pressure etc<br>* Other names: Not actual;|
| Active Comparator: COMPLEX<br>An combination of transpulmonary thermodilution and continuous monitoring of central venous saturation was used to guide hemodynamic therapy after combined valve repair surgery. | Device: transpulmonary thermodilution + central venous saturation<br>* Described in details above<br>* Other names: Non actual;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality rate at Day 28 | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fit for discharge | Formal 'fit for discharge from ICU' criteria | non actual | 
| Vasoactive support | Duration of vasopressor and or inotrope support | 7 days | 
| Duration of respiratory support | The total duration of the respiratory support | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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valve repair, postoperative period, goal-directed therapy, pulmonary artery catheter, transpulmonary thermodilution, central venous oxygen saturation