Condition category
Circulatory System
Date applied
28/08/2008
Date assigned
29/10/2008
Last edited
08/04/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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
r.ascione@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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.

As of 01/05/2012, the anticipated end date of trial has been updated from 31/05/2011 to 31/08/2014.

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.

Ethics approval

The study was finally approved by North Somerset & South Bristol REC on 25th February 2010 (REC ref. no.: 10/H0106/1). (New application submitted when study found to be classed as a CTIMP)

Study design

Single-centre, randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below 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

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 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 (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

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

http://www.uhbristol.nhs.uk/research-innovation/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes