Health Condition 1: I00-I99- Diseases of the circulatory system
Conditions
Interventions
Intervention1: Febuxostat: 80mg dose to be given preoperatively at 12 hours and 2 hours prior surgery
Control Intervention1: Placebo: one dose to be given 12 hours and 2 hours before surgery
Sponsors
AIIMS
Eligibility
Inclusion criteria
Inclusion criteria: As per parameters defined above all adult patients undergoing cardiac surgery under with overall EUROSCORE II Specific parameters: - - Age 18- 65 - Elective and Urgent procedure - Weight of procedure – 1. Isolated CABG 2. Isolated non-CABG major procedure (e.g. single valve procedure, replacement of ascending aorta, correction of septal defect, etc) 3. 2 major procedures (e.g. CABG and AVR), or CABG and mitral valve repair (MVR), or AVR and replacement of ascending aorta, or CABG and maze procedure, or AVR and MVR, etc
Exclusion criteria
Exclusion criteria: 1 Cyanotic heart disease 2 Off pump procedure, DHCA 3 Emergency and salvage procedures 4 =3 major procedures (e.g. AVR, MVR, and CABG, or MVR, CABG, and tricuspid annuloplasty, etc), or aortic root replacement when it includes AVR or repair, coronary reimplantation, and root and ascending replacement 5 Severe renal dysfunction - =50 mL/min - On dialysis (regardless of serum creatinine) 6 NYHA Class IV: symptoms at rest 7 Poor (LVEF 21-30%), Very poor (LVEF =20%) 8 Active infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the attenuation of myocardial ischemic-reperfusion injury between adult patients undergoing cardiac surgery, given febuxostat preoperatively (interventional arm) and placebo preoperatively ( non-interventional arm) Timepoint: 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess attenuation of cardiac injury markers and inflammatory markersTimepoint: 24 hours;To assess presence of Low cardiac output syndrome by inotrope score and clinicallyTimepoint: 24 hours;To assess rhythm disturbance if anyTimepoint: 24 hours | — |
Countries
India
Contacts
Public ContactTanushree kar
AIIMS
Outcome results
None listed