Valvular Heart Disease
Conditions
Keywords
valve repair, postoperative period, goal-directed therapy, pulmonary artery catheter, transpulmonary thermodilution, central venous oxygen saturation
Brief 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 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.
Interventions
the data s=derived from PAC included pulmonary artery occlusion pressure etc
Described in details above
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | Day 28 | Mortality rate at Day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fit for discharge | non actual | Formal 'fit for discharge from ICU' criteria |
| Vasoactive support | 7 days | Duration of vasopressor and or inotrope support |
| Duration of respiratory support | Day 7 | The total duration of the respiratory support |
Countries
Russia