VeRDiCT: volume replacement vs. usual care in diabetics having CABG

• Research type

  Research Study

• Full title

  Preoperative volume replacement vs. usual care in diabetic patients having CABG surgery: a randomised controlled trial

• IRAS ID

  27974

• Sponsor organisation

  University Hospitals Bristol NHS Foundation Trust

• Eudract number

  2009-013159-31

• ISRCTN Number

  ISRCTN02159606

• Research summary

  Diabetes is a major risk factor for post-operative complications and mortality in patients having coronary artery bypass grafting (CABG). Post-operative complications pose a serious threat to patients and prolong a patient??s length of stay in intensive care and hospital. Diabetic patients having CABG have poorer outcomes than non-diabetics, which may be in part because of a lack of evidence to optimise care rather than an intrinsic risk from diabetes. Kidney injury is one of the most serious complications which is more common after CABG in diabetics than in non-diabetics. Pre-operative volume depletion, or dehydration, is associated with renal impairment which, in turn, may lead to acute kidney injury. Givinflud intravenously by a ??drip?? (preoperative volume replacement therapy) is reported to improve kidney function and we want to investigate whether it will reduce recovery time and post-operative renal impairment in diabetics. We propose to carry out a study to answer this question, allocating study patients randomly (like tossing a coin) to pre-operative volume replacement or routine care so that all other patient characteristics are similar in the two groups. We want to recruit diabetic adults aged >16 years and <80 years who are having elective or urgent first time CABG to the study. The primary outcome is the time from surgery until the patient is considered 'fit for discharge' from hospital. We will also study other outcomes including: patients?? views about the quality of their outcome, frequency of acute kidney injury, serial measures of renal function, length of stay in intensive care and the hospital and the need for other hospital resources.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  10/H0106/1

• Date of REC Opinion

  25 Feb 2010

• REC opinion

  Further Information Favourable Opinion