Health Condition 1: I359- Nonrheumatic aortic valve disorder, unspecified Health Condition 2: I349- Nonrheumatic mitral valve disorder, unspecified Health Condition 3: I379- Nonrheumatic pulmonary valve disorder, unspecified Health Condition 4: I369- Nonrheumatic tricuspid valve disorder, unspecified Health Condition 5: I998- Other disorder of circulatory system Health Condition 6: I089- Rheumatic multiple valve disease,unspecified
Conditions
Interventions
Intervention1: Goal-Directed MAP with Sequential Ultrafiltration Strategy: All patients in the Interventional Group will receive Goal-Directed MAP (65 80 mmHg) with
DO2i 280 mL/min/m and Cardiac ind
Sponsors
Sri Ramachandra Institute of Higher Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: Age eighteen to eighty years. Elective cardiac surgery requiring full cardiopulmonary bypass. EuroSCORE II between two and ten. Ejection fraction between thirty and fifty percent. Serum creatinine two milligrams per deciliter or less. Estimated glomerular filtration rate between thirty and fifty-nine milliliters per minute per one point seven three square meters. Glycated hemoglobin eight percent or less for participants with diabetes mellitus. Hemoglobin between eight and twelve grams per deciliter. Total leukocyte count between four thousand and fifteen thousand per microliter. Partial thromboplastin time between twenty-five and thirty-five seconds. Prothrombin time between eleven and fourteen seconds. International normalized ratio one point five or less. C-reactive protein ten milligrams per liter or less. Blood lactate four millimoles per liter or less. Written informed consent obtained.
Exclusion criteria
Exclusion criteria: Emergency cardiac surgery. Redo cardiac surgery. Preoperative mechanical ventilation. Chronic kidney disease Stage Four or higher, with estimated glomerular filtration rate less than thirty milliliters per minute per one point seven three square meters. Severe liver dysfunction with Child Pugh Class greater than Class A. Active inflammatory or autoimmune disease. Deep hypothermic circulatory arrest procedures. Ventricular assist device implantation. Heart transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in coagulation dynamics and reduction in early multi-organ dysfunction following cardiopulmonary bypassTimepoint: 6, 12, 24 hours postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative blood loss and blood transfusion requirementTimepoint: 0 to 24 hours postoperatively;Duration of mechanical ventilationTimepoint: Until extubation;ICU length of stayTimepoint: Until ICU discharge;Hemodynamic stabilityTimepoint: Intraoperative and first 24 hours postoperatively;Re-exploration for bleedingTimepoint: During index hospital admission;Exploratory subgroup analysis in diabetic patients HbA1c greater than 6.5 percentTimepoint: At completion of study;Exploratory subgroup analysis in patients with EF 30 to 40 percentTimepoint: At completion of study | — |
Countries
India
Contacts
Public ContactDr T Periyasamy
Sri Ramachandra Institute of Higher Education and Research
Outcome results
None listed