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临床试验/CTRI/2016/07/007111
CTRI/2016/07/007111已完成不适用

Comparison of Different Rates of Intraoperative Fluid Therapy on Early Graft Function during Live Related Renal Transplantation

ALL INDIA INSTITUTE OF MEDICAL SCIENCES1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年1月8日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Serum creatinine level on postoperative day 1 in patients receiving fluid according to two different fluid regimens

研究概览

简要总结

Renal transplantation is now being recognized as treatment of choice for patients of end stage renal disease. Several studies in the previous decades have shown that the hemodynamic status of the patient during transplantation have effect on graft function . Early graft function is crucial for successful kidney transplantation. Many factors affect graft function. Some of them are donor age, donor hypertension, prolonged anastomosis time, preoperative dialysis with too much ul­trafiltration causing volume contraction in the recipient and pelvic atherosclerosis . Prolonged cold ischemia time and warm ischemia time also have significant effect on graft function. Among all the factors affecting graft outcome, recipient hydration status at time of de-clamping of the vessels after graft anastomosis is also an important factor for the development of delayed graft function. For proper functioning of graft in early post-operative period, it is necessary that graft is adequately perfused at the time of operation.

Patient with chronic renal failure have narrow margin of safety with intravenous hydration and may oscillate between hypovolemia and hypervolemia . Fluid given too fast may theoretically lead to cardiac decompensation and signs of fluid overload in patients with poor cardiac function while on the other hand fluid restriction may lead to hypotension and acidosis in patients with chronic renal failure . Thus intravascular volume and arterial blood pressure needs to be carefully adjusted for effective perfusion of graft as well as to avoid over hydrating the patient. Traditionally fluid replacements for patients undergoing surgery is done according to volume deficit due to overnight fasting, maintenance fluid therapy according to Segar’s formula, intraoperative losses and third space losses . Fluid given according to above calculation may be redistributed by the time of declamping of vessels leading to inadequate graft perfusion. This study, thus has been planned to compare the different fluid hydration regimens, traditional fluid replacement method and targeted fluid replacement before declamping of renal vessels, on early graft function during live related renal transplantation. This study will also evaluate if different regimens will have any hemodynamic or metabolic side effects.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing live related renal transplantation.
  • Donor graft is procured by laparoscopic nephrectomy.

排除标准

  • Severe left ventricular dysfunction Cardiomyopathy with ejection fraction less than 40%.
  • Diabetics Post dialysis hemoglobin less than 8 gm % Severe pulmonary disease and liver disease Refusal to participate in the study Vascular anomaly of donated organ Intraoperative transfusion of blood.

结局指标

主要结局

Serum creatinine level on postoperative day 1 in patients receiving fluid according to two different fluid regimens

时间窗: Serum creatinine level on postoperative day 1 in patients receiving fluid according to two different fluid regimens

次要结局

  • Fall in serum creatinine ,blood urea and serum electrolytes as compared to Preoperative level(patient followed till post op day 6)
  • Onset of urine production in graft after declamping of vessels(immediately after declamping of renal artery)
  • 4 hour urine output after declamping of vessels(4 hours following declamping)
  • 24 hour urine output(post op day 1)
  • Need for postoperative hemodialysis(till post op day 6)
  • Any signs of fluid overload(till post of day 6)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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