E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Coronary artery bypass grafting in diabetic patients |
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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 |
The VeRDiCT Trial is proposed to test the hypothesis that the postoperative incidence of renal insufficiency will be lower, and post-operative recovery faster, if diabetic patients are treated with volume replacement therapy prior to surgery. This treatment has already been shown to prevent acute kidney injury in certain clinical scenarios. Our principal objective is to compare the time from surgery until the patient is 'fit for discharge' in diabetics having coronary artery bypass surgery, randomly assigned to either receive preoperative volume replacement therapy, or to not (i.e. routine care). |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to compare other outcomes between the two groups having volume replacement therapy or routine care: (a) A participant’s judgement about his or her readiness for discharge when the above criteria are met (too soon, about right, could have been discharged earlier); (b) Estimated glomerular filtration rate (GFR) from serum creatinine measured from blood samples collected preoperatively, and at 0, 12, 24, 36, 48, 72, 96 and 120 hours after the operation) and the % of participants with GFR<60 mL/min on 2 of the 7 post-operative times; (c) Microalbumin/creatinine ratio measured in urine samples collected preoperatively and at 0, 24, and 48 hours to assess microvascular disease and renal glomerular injury (d) Tubular injury as expressed by by N-acetyl glucosaminidase (NAG) release measured in urine samples collected preoperatively and at 0, 24, and 48 hours in a consecutive sub-sample of 80 patients. (e) Acute Kidney Injury (AKI, doubling of basel |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria: 1. Patients with diagnosed type I or type II diabetes, being treated with oral medication and/or insulin (i.e. not diet controlled only); 2. Age >16 and <80 years; 3. Undergoing elective or urgent, isolated first time CABG with or without CPB; 4. Left ventricular ejection fraction ≥30%. |
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E.4 | Principal exclusion criteria |
Exclusion criteria: 1. Patients who have had previous cardiac surgery; 2. Emergency or salvage operation; 3. Chronic renal failure requiring dialysis; 4. Current congestive heart failure; 5. Left ventricular ejection fraction <30%. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome is the time until patients are classified as ‘fit for discharge’, since renal impairment is expected to impact on the risk of many post-operative complications. A patient must have normal temperature, pulse and respiration, normal oxygen saturation on air, normal bowel function and be physically mobile in order to be classified as fit for discharge |
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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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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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End of the trial is the last visit of the last subject undergoing the trial (last 'visit' is by postal questionnaire to home, 3 months post surgery). |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 7 |