Comparison of perioperative protocolized fluid regimen based on ERAS with standard fluid regimen in recipients undergoing kidney transplantation. A Randomised control equivalence trial.
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time to normalization of creatinine in days
概览
简要总结
Fluid therapy during Kidney Transplant is among the most challenging clinical tasks. Optimal fluid management has been shown to decrease delayed graft function after kidney transplant, which is associated with improved patient survival and long-term function, and decreased acute rejection. The choice between the use of vasopressors and fluids for hypotension is too simplistic in most cases. Implementing cardiac output monitoring could help guide adequate fluid resuscitation. The general approach to fluid resuscitation in patients undergoing major surgery based on current evidence should be as much as required, as little as possible. Traditionally, the perioperative volume infusion regimen in kidney transplant has been guided by central venous pressure as an estimation of the patient’s volume status and mean arterial pressure. However excessive volume infusion to the point of no further fluid responsiveness can damage the endothelial glycocalyx and is no longer considered to be the best approach. Achievement of adequate flow to maintain sufficient tissue perfusion without maximization of cardiac filling remains a challenge.ERAS adopts a multimodal, multidisciplinary approach to provide seamless perioperative care of the surgical patient. ERAS pathways should include a team consisting of surgeons, anesthesiologists, an ERAS coordinator, nursing and other staff from units that care for the surgical patient. The implementation of ERAS protocols has resulted in significant benefits to both the patients and hospitals with a shorter length of hospital stay by 30–50%, a similar rate of complication decrease, and a significantly reduced re-admissions rate to the hospital. An emerging component and a key element for the success of Enhanced Recovery After Surgery (ERAS) protocols has been the concept of goal-directed fluid therapy (GDT). GDT related to ERAS protocols attempts to minimize complications associated with fluid imbalance during surgery.
In our study, we hypothesize that our protocolised fluid therapy based on ERAS would be equivalent in time to normalization of creatinine in kidney transplant recipients, as compared to the standardized fluid therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor 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
- •Kidney transplant recipients between 18 to 65 years of age.
排除标准
- •1.Combined transplantation 2.Cadaveric kidney transplant 3.Age less than 18 years 4.Refused to give consent.
结局指标
主要结局
Time to normalization of creatinine in days
时间窗: Baseline | day 1 | day 3 | day 7 | day 30
次要结局
- Length of stay in hospital for donor & recipient. Length of stay in ICU for donor & recipient. Time to return of normal bowel movements. Time to return to ambulation.(Baseline)
研究者
Rick Bose
Postgraduate Institute of medical education and research, Chandigarh