Sodium Bicarbonate for kidney protection in patients undergoing liver transplantation
Sodium Bicarbonate To Prevent Increases in Serum Creatinine After Orthotopic Liver Transplantation: a Pilot Double-Blind, Randomized Controlled Trial.
Austin Hospital
60 participants
Nov 28, 2010
Interventional
Conditions
Summary
Acute renal failure is a common and serious postoperative complication of orthotopic liver transplantation. The reported incidence ranges from 17% to 95% and severe renal failure requiring renal replacement therapy occurs in 5% - 35% of patients after transplantation. Renal failure requiring haemodialysis post liver transplant, irrespective of pre-transplant dialysis status, is a profound risk factor for death. Identifying the risk factors for renal dysfunction after liver transplantation and developing therapeutic approaches to prevent, halt, or ameliorate de novo renal dysfunction or retard the progression of preexisting renal dysfunction should be fundamental goals in managing these patients. Sodium bicarbonate is a drug in common use for the prevention of contrast nephropathy and has been shown to be effective in preventing acute kidney injury in patients undergoing cardiac surgery. It is used to effectively treat severe metabolic acidosis in critically ill patients. It is possible that sodium bicarbonate might reduce the oxidative stress which occurs during liver transplantation and so decrease or prevent acute kidney injury in these patients. This is an investigator initiated, pilot, double-blind, randomized controlled trial. The purpose of this study is to determine whether administration of sodium bicarbonate reduces the risk of kidney injury, and also reduces some of the cellular changes and oxidative stress known to cause kidney injury after orthotopic liver transplantation. Adult patients undergoing orthotopic liver transplanation will be randomized to receive either sodium bicarbonate or placebo for the duration surgery. Primary outcome: a rise in the serum creatinine to > 1.5 times the baseline value or decreased GFR > 25% (RIFLE class ‘R’) measured 72 hours postoperatively. Secondary outcomes: To examine changes in peak serum and urinary NGAL and peak serum cystatin C (sensitive biomarkers of acute renal injury) compared to baseline, peak changes in delta creatinine, acid– base status. Other outcomes collected will include duration of ICU stay, duration of hospital stay, all adverse events including institution of renal replacement therapy and hospital mortality. Recruiting hospitals: Austin Hospital Number of participants planned: 60
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Interventions
Sodium Bicarbonate 8.4% At our institution, sodium bicarbonate is presented in glass bottles of 100 mL, each containing 100 mmol of an 8.4% sodium bicarbonate solution. The concentration of the 8.4% bicarbonate solution is 2000 mOsm/kg. This 8.4% solution is a molar solution and therefore contains 1 mmol of HC03- per each ml. Loading dose: A loading dose of 0.5 ml/kg (equivalent to 0.5 mmol/kg Sodium Bicarbonate 8.4%) will be administered over 1 hour, commencing immediately after the induction of anaesthesia and before the first surgical incision. Maintenance dose: A continuous maintenance infusion will then be delivered at 0.15 ml/kg/hr (equivalent to 0.15 mmol/kg/hr Sodium Bicarbonate 8.4%) infused over the course of the surgery and discontinued at the completion of surgery at skin closure. The loading dose and infusion will be into a central venous catheter (that is routinely inserted for this procedure) via a computerised syringe pump or volumetric infusion pump. Dosing example: a 70kg patient will receive a loading dose of 0.5 mmol/kg, which is 35 mmol, or 35 ml of the 8.4% sodium bicarbonate solution. This will be followed by a continuous infusion of 0.15 mmol/kg/hr, which is 10.5 mmol per hour, or 10.5 ml per hour of the 8.4% sodium bicarbonate solution.
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ACTRN12611001290987