Pre-operative volume replacement versus usual care in diabetic patients having coronary artery bypass graft (CABG) surgery: a randomised controlled trial

Conditions

Coronary heart disease and diabetes Circulatory System Chronic ischaemic heart disease

Thirard R, Ascione R, Blazeby JM, Rogers CA.

2020-12-104 citations

Preoperative VolumE Replacement therapy in DIabetic patients undergoing coronary artery bypass grafting surgery: results from an open parallel group randomized Controlled Trial (VeRDiCT)

Kunal Sarkar, Rosie A Harris, Sian Wells, Tracy Harris, Madeleine Clout et al. (15 authors)

Interactive Cardiovascular and Thoracic Surgery2019-09-098 citations

10.1093/icvts/ivz226

The Effects of Preoperative Volume Replacement in Diabetic Patients Undergoing Coronary Artery Bypass Grafting Surgery: Protocol for a Randomized Controlled Trial (VeRDiCT Trial)

Madeleine Clout, Tracy Harris, Chris Rogers, Lucy Culliford, Jodi Taylor et al. (12 authors)

JMIR Research Protocols2017-06-191 citations

10.2196/resprot.7386

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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 =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%

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% (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%

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed