E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 < 1) • No participation in another clinical study (AMG) at the time of this study 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
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E.4 | Principal 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 < 1%) or breastfeeding is present or • Contraindications against the study medication are present such as alkalosis or hypokalemia or hypernatremia or • Absent willingness to allow storage or circulation of coded data collected for study reason or • Patient is accomodated in an institution of mental disorders on judicial or magisterial behalf or • Patients participate in another clinical study (AMG) or • Pre-operative end stage renal disease (serum creatinine >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.
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |