Cardiac surgical patients in whom the use of cardiopulmonary bypass is planned and having at least one ore more of the following risk factors for post-operative acute kidney injury • Age = 70 years • Preoperative plasma creatinine >120 µmol/L • Heart failure (NYHA class III / IV) • Insulin dependent diabetes mellitus • Valve surgery (with or without coronary artery bypass graft surgery) • Redo cardiac surgery
Conditions
Interventions
Trade Name: Sodium bicarbonate
Pharmaceutical Form: Intravenous infusion
CAS Number: 144-55-8
Other descriptive name: SODIUM BICARBONATE
Concentration unit: mmol millimole(s)
Trade Name: Sodium chlor
Sponsors
Charité Universitaetsmedizin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cardiac surgical patients in whom the use of cardiopulmonary bypass was planned and: • Written informed consent of patient • No present pregnancy • Highly effective contraception in women with childbearing potential (Pearl index 120 µmol/L • Heart failure (NYHA class III / IV) • Insulin dependent diabetes mellitus • Valve surgery (with or without coronary artery bypass graft surgery) • Redo cardiac surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Cardiac surgical patients will not be considered eligible if: • The use of cardiopulmonary bypass is not planned (off-pump cardiac surgery) or • An emergency operation is indicated (within 24 hours after first description of cardiac symptoms) • The above mentioned risk definition for post-operative acute kidney injury is not fulfilled or • Women of childbearing age without highly effective contraception (PEARL-Index 300 µmol/L) is present or • Known blood-borne infectious disease is present or • Chronic moderate to high dose corticosteroid therapy (>10 mg/d prednisone or equivalent) is present or • Age is below 18 years, • Legal responsibility • Persons who are detained officially or legally to an official institute.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether sodium bicarbonate administered intravenously from the time of induction of anaesthesia prior to cardiac surgery and for 24 hours postoperatively results in a decreased proportion of patients developing CPB-associated postoperative AKI defined as an increase in plasma creatinine concentration from preoperative value to peak value greater than 25% or greater than 44µmol/L within the first 5 days postoperatively compared to placebo.;Secondary Objective: To investigate the effect of sodium bicarbonate compared to placebo on the following variables: • change in plasma creatinine concentration from baseline to peak value within the first 5 days after cardiac surgery • change in urine pH from baseline to 24 hours after cardiac surgery • change in urine concentration of neutrophil gelatinase associated lipocalin (NGAL) from baseline to 24 hours after cardiac surgery • change in urine concentration of a marker of oxidative stress from baseline to 24 hours after cardiac surgery • change in plasma concentration of neutrophil gelatinase associated lipocalin (NGAL) from baseline to 24 hours after cardiac surgery • change in plasma concentration of a marker of oxidative stress from baseline to 24 hours after cardiac surgery • change in activity of NFkappaB from baseline to 24 hours after cardiac surgery • need for renal replacement therapy • duration ICU stay • duration of hospital stay • 90 day mortality;Primary end point(s): To investigate whether sodium bicarbonate administered intravenously from the time of induction of anaesthesia prior to cardiac surgery and for 24 hours postoperatively results in a decreased proportion of patients developing CPB-associated postoperative AKI defined as an increase in plasma creatinine concentration from preoperative value to peak value greater than 25% or greater than 44µmol/L within the first 5 days postoperatively compared to placebo. | — |
Countries
Germany, Ireland
Outcome results
None listed