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

Interact Cardiovasc Thorac Surg. 2020 Jan 1;30(1):54-63. doi: 10.1093/icvts/ivz226.

Abstract

Objectives: To investigate the effect of preoperative volume replacement therapy (VRT) on renal function, health outcome and time to fitness for discharge in diabetic patients undergoing coronary artery bypass grafting (CABG).

Methods: In 2 parallel randomized controlled trials, diabetic patients were allocated to preoperative VRT (1 ml/kg/h of Hartmann's solution for 12 h) or usual care. Primary outcome was time to fitness for discharge. Secondary outcomes included acute kidney injury, postoperative complications, patient-reported quality of life (QoL), hospital resource use and markers of renal, cardiac and inflammatory injury.

Results: In total, 169 patients were randomized (84 VRT, 85 usual care; mean age 64 years; 88% male). Time to fitness for discharge was similar between groups [median 6 days; interquartile range 5.0-9.0 in both groups; hazard ratio 0.95, 95% confidence interval (CI) 0.65-1.38; P = 0.78]. Postoperative acute kidney injury was not statistically different (VRT: 27.7% vs usual care: 18.8%, odds ratio 1.72, 95% CI 0.82-3.59; P = 0.15). Estimated glomerular filtration rate (mean difference -0.92, 95% CI -4.18 to 2.25; P = 0.56), microalbumin/creatinine ratio [geometric mean ratio (GMR) 1.16, 95% CI 0.94-1.42; P = 0.16], N-acetyl-beta-d-glucosaminidase (GMR 1.08, 95% CI 0.83-1.40; P = 0.57), C-reactive protein (GMR 1.00, 95% CI 0.88-1.13; P = 0.94), troponin T (Trop-T; GMR 1.18, 95% CI 0.78-1.79; P = 0.39) and other secondary health outcomes were similar between groups. QoL improved in both groups at 3 months with no difference observed.

Conclusions: The use of preoperative VRT is not superior to usual care in diabetic patients undergoing CABG.

Clinical trial registration number: ISRCTN02159606.

Keywords: Coronary artery bypass grafting; Diabetes mellitus; Renal failure; Volume replacement therapy.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Kidney Injury / etiology
  • Acute Kidney Injury / prevention & control*
  • Aged
  • Coronary Artery Bypass / adverse effects*
  • Coronary Artery Disease / complications
  • Coronary Artery Disease / surgery*
  • Diabetes Complications / complications*
  • Female
  • Fluid Therapy / methods*
  • Glomerular Filtration Rate
  • Humans
  • Kidney / physiopathology
  • Male
  • Middle Aged
  • Odds Ratio
  • Patient Discharge
  • Postoperative Complications / etiology
  • Postoperative Complications / prevention & control*
  • Proportional Hazards Models
  • Quality of Life

Associated data

  • ISRCTN/ISRCTN02159606