Comparison of Plasmalyte A, Normal Saline and Ringer Lactate as Intraoperative Fluids in Patients Undergoing Renal Transplantation.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- acid base balance, 4 readings intraoperaively to be taken using arterial blood sample of the patient
研究概览
简要总结
Fluid management being an important component of surgery becomes more challenging for an anesthesiologist in case of renal transplant. Ischemia-reperfusion injury is an inevitable consequence of kidney transplantation, leading to metabolic acidosis .Normal saline (NS; 0.9% NaCl) is administered during kidney transplantation to avoid the risk of hyperkalemia associated with potassium-containing fluids. Plasmalyte is another fluid which can be used and probably will lead to better metabolic profile in these group of patients.The primary objective of this study will be to compare the effects of using normal saline (NS), Ringer lactate and Plasmalyte as intravenous fluids on acid-base balance and electrolytes during living donor kidney transplantation. Secondary outcomes assessed will be the effect on renal function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing elective living donor renal transplant
排除标准
- 未提供
研究组 & 干预措施
normal saline
Intravenous fluid used in these patients would be normal saline which would be given intravenously during intraoperative and postoperative period
干预措施: intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE (Drug)
ringer lactate
Intravenous fluid used in these patients would be ringer lactate which would be given intravenously during intraoperative and postoperative period
干预措施: intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE (Drug)
plasmalyte A
Intravenous fluid used in this arm in patients would be plasmalyte A which would be given intravenously during intraoperative and postoperative period
干预措施: intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE (Drug)
结局指标
主要结局
acid base balance, 4 readings intraoperaively to be taken using arterial blood sample of the patient
时间窗: during the surgery
pH, pCO2, pO2, HCO3,Base deficit, Na, K are the values normally measured in acid base analysis
次要结局
- serum creatinine on day 1, 2 and 7 of surgery(day 1, 2 and 7)
- intraoperative hemodynamics in all patients(intraoperatively)
研究者
Dr Vikas Saini
Associate Professor
Post Graduate Institute of Medical Education and Research, Chandigarh