Contact information
Type
Scientific
Primary contact
Prof Raimondo Ascione
ORCID ID
Contact details
Bristol Heart Institute
Level 7 Queens Building
Bristol Royal Infirmary (BRI)
Marlborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 34 23286
r.ascione@bristol.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Pre-operative volume replacement versus usual care in diabetic patients having coronary artery bypass graft (CABG) surgery: a randomised controlled trial
Acronym
VeRDiCT
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.
Ethics approval
North Somerset & South Bristol REC, 25/02/2010, ref: 10/H0106/1
Study design
Single-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Coronary heart disease and diabetes
Intervention
Current interventions as of 01/05/2012
1. Volume replacement: CABG with or without cardiopulmonary bypass (CPB), with preoperative volume replacement therapy (1 ml/kg/hr of Hartmann's solution for 12 consecutive hours prior to surgery).
2. Usual care: CABG with or without CPB with conventional preoperative management (no preoperative fluids).
Previous 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)
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
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 measures
Current secondary outcome measures as of 08/04/2013 (changes implemented as of 16/01/2013):
1. A participants 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 (eGFR) from serum creatinine measured from blood samples collected preoperatively (baseline, pre-trial intervention), 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 8 post-operative times;
3. Microalbumin/creatinine ratio measured in urine samples collected preoperatively (baseline, pre-trial intervention) and at 0, 24, 48 and 120 hours to assess microvascular disease and renal glomerular injury.
4. Tubular injury as expressed by N-acetyl glucosaminidase (NAG) release measured in urine samples collected preoperatively (baseline, pre-trial intervention) and at 0, 24, 48 and 120 hours in a consecutive sub-sample of 50 patients.
5. Acute Kidney Injury (AKI, doubling of baseline serum creatinine at any time); serum creatinine will be measured from blood samples collected preoperatively (baseline, pre-trial intervention) 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 myocardial infarction (MI), stroke, arrhythmia, need for haemodynamic support, renal failure and wound infection (including 6-8 week telephone ASEPSIS assessment);
7. 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;
8. Coronary Revascularisation Outcome Questionnaire (CROQ) preoperatively (preoperative version) and at 3 months.
9. The following outcomes will be measured in a consecutive sub-sample of 40 patients.
9.1. Preoperative blood glucose control, as measured by fasting blood glucose and haemoglobin A1c (HbA1c) prior to chest opening but after the intervention.
9.2. MicroRNA and other biochemical predictors of health outcome in serum and plasma taken preoperatively (baseline, pre-trial intervention) and at 0, 24 and 120 hours after the operation, and also in any leftover material/specimens collected during surgery (this may include, but is not limited to: portions of internal mammary arteries with surrounding tissues, pericardial fluid, pericardial fat/adipose tissue, pericardium, waste blood).
9.3. C-reactive protein as a marker of inflammation, measured preoperatively (baseline, pre-trial intervention) and at 0, 12, 24, 48, 72 and 120 hours after the operation.
9.4. Cardiac damage as measured with serial troponin T release measured pre-operatively (baseline, pre-trial intervention) and at 0, 12, 24, 48, 72 and 120 hours after the operation.
Previous secondary outcome measures as of 01/05/2012:
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 8 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 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
Overall trial start date
01/06/2009
Overall trial end date
31/08/2014
Reason abandoned (if study stopped)
Eligibility
Participant 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%
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
170
Participant 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%
Recruitment start date
01/06/2009
Recruitment end date
31/08/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bristol Heart Institute
Bristol
BS2 8HW
United Kingdom
Sponsor information
Organisation
University Hospitals Bristol NHS Foundation Trust (UK)
Sponsor details
Research and Innovation
Education Centre Level 3
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Garfield Weston Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28630035