None listed
Conditions
Brief summary
Background: Fifty people die every day in Australia with kidney related disease with recent data from December 2009 showing that 1,105 of the 10,341 people receiving dialysis (11%) were on the renal transplant waiting list. Only about 6% receive a transplant each year and when patients present for transplantation, intravenous fluid therapy is critical to ensure optimal graft perfusion and function. Fluid therapy is important to maintain intravascular volume during and after kidney transplantation whilst avoiding metabolic and electrolyte disturbances which may further compromise graft function. Traditionally normal saline (NS) or potassium-free fluids are the IV fluid therapy of choice in the perioperative period for patients undergoing kidney transplantation. The rationale for using NS is the avoidance of the administration of large volumes of potassium which is present in small concentrations in Plasmalyte solution (5mmol/L). The potassium contained in Plasmalyte solution may contribute to hyperkalemia although current evidence suggests that balanced fluid solutions may confer clinical benefits over NS as the administration of large volumes of NS has been strongly associated with the development of hyperchloremic metabolic acidosis which in turn may cause hyperkalemia through an extracellular shift of potassium. Study rationale: There are very few studies comparing the different types of crystalloid fluids that patients receive when undergoing renal transplantation. In order to prevent delayed graft function it is common for patients to receive 4 to 8 litres/day of crystalloid therapy per day to maintain sufficient intravascular volume. The commonest fluid used for patients undergoing renal transplantation at Austin Hospital is 0.9% Normal Saline, however its use is associated with severe metabolic disturbances. There is emerging evidence that for patients undergoing renal transplantation who receive a balanced crystalloid instead of Normal Saline, there may be beneficial effects on the incidence of early allograft dysfunction and electrolyte disturbances. Hypothesis: When used as crystalloid therapy for patients undergoing renal transplantation will the balanced crystalloid fluid Plasmalyte Solution, have more favourable effects on metabolic acidosis and early graft function compared to 0.9% Normal Saline. Study design: Single centre randomised controlled blinded study. Inclusion criteria: Adult patients (age > 18years) undergoing deceased donor renal transplantation (heart-beating or non heart-beating). Primary endpoint: 1. Standard base deficit immediately post surgery in the Post Anaesthesia Care Unit and at 24 hours & 48 hrs postoperatively 2. Serum potassium levels in the Post Anaesthesia Care Unit and at 24 hours & 48 hrs postoperatively 3. Serum Creatinine Secondary endpoints: 4. Strong-ion-difference 5. Serum Albumin 6. Serum Phosphate 7. Renal biomarkers including: serum and urine NGAL and Cystatin C 8. Requirement for Renal Replacement Therapy 9. Duration of Hospital Stay 10. Adverse events including myocardial infarction, pneumonia, cardiac arrythmias, pulmonary embolism, heart failure 11. Death within 30 postoperative days No of participants: 50 Recruiting Hospital: Austin Hospital Clinical significance: A finding that Plasmalyte solution has more favourable effects on renal transplant associated acidosis, strong-ion difference, hyperkaleamia and delayed graft function may influence the fluid chosen for patients undergoing renal transplantation.
Interventions
Plasmalyte 148 Intravenous Fluid Solution Plasma-lyte 148 (pH 7.4) is a replacement electrolyte intravenous infusion that provides electrolyte supplementation and water for hydration for patients undergoing major surgery including renal transplantation. In addition, the presence of bicarbonate precursors (acetate and gluconate) produces a metabolic alkalinising effect that helps counteract metabolic acidosis of patients with chronic kidney disease. It is an isontonic solution and compatible with blood or blood components. It may be added to or infused concurrently with blood components, or used as a diluent in the transfusion of packed erythrocytes. The electrolyte composition of Plasmalyte is as follows: Magnesium chloride .3 g/L Potassium chloride .37 g/L Sodium acetate 3.68 g/L Sodium chloride 5.26 g/L Sodium gluconate 5.02 g/L For this clinical trial Plasmlayte solution will be used intraoperatively and postoperatively for 48 hours as the intravenous fluid solution for all patients undergoing cadaveric renal transplantation in our institution. Doses: The volume of Plasmlayte solution will be delivered based on routine clinical care under the guidance of the anaesthetists and renal physician. The fluid will be commenced immediately after the induction of anaesthesia and before the first surgical incision and discontinued after 48 post operative hours. Intraoperatively: Plasmalyte will be given as per conventional anaesthesia practice with 10–30 mL/kg/hr to maintain mean arterial pressure (MAP) within 20% of baseline preoperative value. Postoperative Management: Postoperatively as per renal unit protocols all patients will receive a maintenance infusion of Plasmalyte solution. The rate of the study fluid replacement is determined by the urine output as a “urine chaser”. Each hour the previous hour’s urine output + 30 ml will be replaced with trial fluid. The “urine chaser” is commenced in the recovery room and continues for the first 24 hours. The treating medical staff may alter the rate of fluid administration as clinically required. Any additional fluid boluses of trial drug crystalloid solution may be administered to any patient if volume supplementation is required. For the next 24-hours (day 2) any further crystalloid infusion consists of the study fluid, with the rate of the crystalloid infusion being at the discretion of the treating medical staff. After 48 hours the study fluid is no longer used and the rate and type of any further crystalloid administration is at the discretion of the treating medical staff.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Adult patients (age > 18years) 2. Deceased donor renal transplantation (heart-beating or non heart-beating)
Exclusion criteria
1. Preoperative hyperkalaemia (serum potassium > 6.0 mmol/L 2. Pregnancy 3. Chronic liver disease (liver function tests > 1.5 X normal value) 4. Known allergic reaction to study solutions 5. Combined liver-kidney transplantation