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| Pre-operative volume replacement versus usual care in diabetic patients having coronary artery bypass graft (CABG) surgery: a randomised controlled trial |
| ISRCTN | ISRCTN02159606 |
| ClinicalTrials.gov identifier | |
| Public title | Pre-operative volume replacement versus usual care in diabetic patients having coronary artery bypass graft (CABG) surgery: a randomised controlled trial |
| Scientific title | |
| Acronym | VeRDiCT |
| Serial number at source | N/A |
| Study hypothesis |
Post-operative incidence of renal insufficiency is lower and post-operative recovery faster, when diabetic patients are treated with volume replacement therapy (VR) prior to surgery.
Please note that extensive amendments have been made to this trial record as of 15/05/2009. These include the following: 1. The anticipated start and end dates of the trial have been updated from 01/01/2009 and 31/12/2010 to 01/06/2009 and 31/05/2011, respectively 2. The target number of participants has been updated from 164 to 170 All other amendments are recorded in the relevant fields. |
| Lay summary | |
| Ethics approval | The study was submitted to Wiltshire REC, meeting was on 7th May 2009 (ref: 09/H0104/31). Approval pending as of 15th May 2009. |
| Study design | Single-centre, randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Coronary heart disease and diabetes |
| Participants - inclusion criteria |
Current inclusion criteria as of 15/05/2009:
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. Both males and females, age >16 and <80 years 3. Undergoing elective or urgent, isolated first time coronary artery bypass graft (CABG) with or without cardiopulmonary bypass (CPB) 4. Left ventricular ejection fraction >=30% Previous inclusion criteria: 1. Patients with diagnosed type I or type II diabetes 2. Both males and females, aged greater than 16 and less than 80 years 3. Undergoing elective or urgent, isolated first time coronary artery bypass graft (CABG) with or without cardiopulmonary bypass (CPB) 4. Left ventricular ejection fraction greater than or equal to 25% |
| Participants - 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% (i.e. poor LV function) Please note that the 5th exclusion criterion was updated as of 15/05/2009. The previous criterion was as follows: 5. Left ventricular ejection fraction less than 25% |
| Anticipated start date | 01/06/2009 |
| Anticipated end date | 31/05/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 170 |
| Interventions |
The participants will be randomly allocated to the following two treatment groups in equal numbers:
1. Volume replacement: CABG with or without CPB, with pre-operative volume replacement therapy (1 ml/kg/hr of normal saline [N/saline] for 12 consecutive hours prior to surgery) 2. Usual care: CABG with or without CPB with conventional pre-operative management (no pre-operative fluids) |
| Primary outcome measure(s) |
Current primary outcome measures as of 15/05/2009:
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. Previous primary outcome measures: Time until patients are classified as 'fit-for-discharge' since renal impairment is expected to impact on the risk of many post-operative complications. In order to be classified as fit for discharge, a patient must have a chest X-ray with no evidence of pleural effusion requiring drainage, lung collapse/consolidation or pneumothorax, no suspected infection, normal routine blood tests and temperature and be physically mobile. |
| Secondary outcome measure(s) |
Current secondary outcome measures as of 15/05/2009:
1. 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) 2. Estimated 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 3. Microalbumin/creatinine ratio measured in urine samples collected preoperatively and at 0, 24, and 48 hours to assess microvascular disease and renal glomerular injury 4. 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. 5. Acute Kidney Injury (AKI, doubling of baseline serum creatinine at any time); serum creatinine will be measured from blood samples collected preoperatively and at 0, 24, 48, 72, 96, and 120 hours; the peak of postoperative serum creatinine level will be used in relation to the preoperative value to calculate the incidence of AKI 6. In-hospital mortality and other standard measures of morbidity as used in previous RCTs, e.g., post-operative MI, stroke, arrhythmia, need for haemodynamic support, renal failure and wound infection (including 4-6 week telephone ASEPSIS assessment) 7. Use of health care resources and associated costs, e.g., duration of operation, ICU/HDU and ward stay, additional interventions to treat complications, readmissions 8. Coronary Revascularisation Outcome Questionnaire (CROQ) preoperatively (preoperative version) and at 3 months Previous secondary outcome measures: 1. A participant's judgment about his or her readiness for discharge when the above criteria are met (too soon, about right, could have been discharged earlier) 2. Estimated glomerular filtration rate (GFR) from serum creatinine measured from blood samples collected pre-operatively, and at 0, 4, 12, 24 and 48 hours after the operation) and the percentage of participants with GFR less than 60 mL/min on two of the five post-operative times 3. Renal glomerular and tubular injury as expressed by microalbumin/creatinine ratio and by N-acetyl glucosaminidase (NAG) release respectively and measured in urine samples collected pre-operatively and at 0, 24, and 48 hours in a consecutive sub-sample of 80 patients 4. Acute renal failure (ARF) (doubling of baseline serum creatinine at any time). Serum creatinine will be measured from blood samples collected pre-operatively and at 0, 24, 48, 72, 96, and 120 hours; the peak of post-operative serum creatinine level will be used in relation to the pre-operative value to calculate the incidence of ARF 5. In-hospital mortality and other standard measures of morbidity as used in previous randomised controlled trials, e.g., post-operative myocardial infarction (MI), stroke, arrhythmia, need for haemodynamic support, renal failure and wound infection (including 4 - 6 week telephone ASEPSIS assessment) 6. Use of health care resources and associated costs, e.g. duration of operation, intensive care unit (ICU)/high dependency unit (HDU) and ward stay, additional interventions to treat complications, readmissions 7. Coronary Revascularisation Outcome Questionnaire (CROQ) pre-operatively (pre-operative version) and at 3 months |
| Sources of funding | Garfield Weston Foundation (UK) |
| Trial website | |
| Publications | |
| Contact name | Mr Raimondo Ascione |
| Address |
Bristol Heart Institute
Level 7 Queens Building Bristol Royal Infirmary (BRI) Marlborough Street |
| City/town | Bristol |
| Zip/Postcode | BS2 8HW |
| Country | United Kingdom |
| r.ascione@bristol.ac.uk | |
| Sponsor | University Hospitals Bristol NHS Foundation Trust (UK) |
| Address |
Research and Development
Education Centre Level 3 Upper Maudlin Street |
| City/town | Bristol |
| Zip/Postcode | BS2 8AE |
| Country | United Kingdom |
| Sponsor website: | http://www.uhbristol.nhs.uk/research.html |
| Date applied | 28/08/2008 |
| Last edited | 15/05/2009 |
| Date ISRCTN assigned | 29/10/2008 |
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| © 2012 ISRCTN unless otherwise stated. | |
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