Perioperative Fluid Management in Patients Receiving Cadaveric Renal Transplants - Effects of Normal Saline Versus Balanced Infusates on the Incidence of Electrolyte and Acid-base Disturbances
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- intra or postoperative hyperkalaemia
研究概览
简要总结
In this study we want to show that the choice of a balanced type fluid solution for the perioperative fluid management of patients receiving cadaveric renal transplantation results in less occurrence of intra- and postoperative hyperkalemia, and thus the need for postoperative dialysis. Additionally, we aim to determine whether the use of a balanced infusion solution leads to less occurrence of metabolic acidosis and electrolyte disorders than the use of isotonic saline.
Furthermore we want to evaluate whether perioperative fluid management with balanced infusion solutions results in a higher frequency of primary graft function than with administration of isotonic saline.
We will test the hypothesis that the use of "Elomel isoton"(Fresenius Kabi Austria GmbH) a balanced infusion solution will result in less occurrence of hyperkalemia and consequent post-transplant dialysis, less occurrence of metabolic acidosis, decreased incidence of electrolyte disorders and higher incidence of primary graft function when compared to isotonic saline for perioperative fluid management in patients receiving cadaveric renal transplantation.
详细描述
Background
Kidney transplantation is the treatment of choice for patients with end-stage-renal-disease (ESRD). Successful renal transplantation improves quality of life and reduces mortality in eligible patients when compared to hemodialysis. In 2007, 44 kidney transplantations per million residents were performed in Austria. The number of patients with a renal transplant has continuously risen in the last ten years. 398 kidney transplantations were performed in Austria in 2007, of which only 61 were of living donors. This underlines the special role of cadaveric kidney transplantation in Austria.
Several studies have demonstrated that adequate intraoperative fluid administration is associated with earlier onset of graft function and improved graft survival in renal transplant recipients. However, which kind of solution should be chosen for the perioperative fluid management of renal transplant recipients remains to be clarified. A non-governmental US survey has shown that normal saline is the most commonly used fluid for renal transplantation. The most common cited reason for the administration of normal saline was the lack of potassium in the solution. Balanced salt type fluids were used in only less than 10% of kidney transplantations.
To our knowledge only three studies compared the effects of lactated ringer's solution versus normal saline in kidney transplantation. Taken together, the application of lactated ringer's solution led to less occurrence of metabolic acidosis, electrolyte derangements and in one study, the appearance of hyperkalemia was eliminated by the use of lactated ringer's instead of normal saline. However, it was also shown that the administration of lactated ringer's during kidney transplantation led to a significant rise in lactate levels compared to those treated with normal salin. Despite the knowledge that lactated ringer's can at least potentially lead to a rise in lactate levels, no studies using acetate based balanced salt type fluids have been performed so far in cadaveric renal transplantation. We therefore propose a prospective study in which patients undergoing cadaveric kidney transplantation will be randomized to receive either a solely acetate buffered balanced salt type fluid or a normal saline for infusion therapy.
Clinical considerations
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with end-stage-renal disease admitted for cadaveric renal transplantation will be included in the study
排除标准
- •Patients younger than 18 years of age
- •Hyperkalemia defined as a serum potassium exceeding 5.5 mmol/L pre-operatively
结局指标
主要结局
intra or postoperative hyperkalaemia
时间窗: 7 days
次要结局
- metabolic acidosis(7 days)
研究者
Eva Meitner
M.D.
Medical University of Vienna
