Norepinephrine Infusion Combined With Goal-directed Fluid Therapy Reduces Delayed Graft Function Incidence in Patients Undergoing Kidney Transplantations: a Randomized Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 380
- 试验地点
- 3
- 主要终点
- The incidence of delayed graft function (DGF)
研究概览
简要总结
Delayed graft function (DGF), delineated by the necessity for dialytic intervention within the initial week post-transplantation, afflicts approximately 20%-50% of recipients. The primary objective of this study is to investigate the potential efficacy of norepinephrine infusion in conjunction with goal-directed fluid therapy (GDFT) in mitigating the occurrence of DGF among individuals undergoing kidney transplantations. The findings of this investigation have the potential to advance the field of perioperative care in kidney transplantations by providing insights into optimized management strategies.
详细描述
Chronic kidney disease (CKD) presents a formidable challenge to global healthcare systems. With ongoing advancements in surgical techniques, kidney transplantation has emerged as a principal therapeutic modality for individuals afflicted with end stage renal disease (ESRD), markedly enhancing their long-term prognosis and overall quality of life postoperatively. Nevertheless, the occurrence of delayed graft function (DGF) represents a prevalent early complication following kidney transplantations, mainly stemming from the ischemia-reperfusion injury incurred by the transplanted kidneys and the utilization of extended criteria donor organs. The manifestation of DGF can precipitate primary allograft nonfunction, acute rejection episodes, and potentially fatal outcomes. Vigilant attention to perioperative fluid management emerges as a cornerstone in mitigating the risk of DGF. Recent strides in goal-directed fluid therapy (GDFT) have garnered substantial attention within critical care contexts, with empirical evidence underscoring its favorable impact on postoperative outcomes in critically ill cohorts. However, the efficacy of GDFT specifically in the context of kidney transplantation remains a subject of ongoing debate and scrutiny. Hence, the imperative arises to investigate potential strategies aimed at attenuating the incidence of DGF in this patient demographic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Recipients aged 18 years or older
- •Scheduled to undergo kidney transplantations under general anesthesia
- •Cadaveric kidney transplantations
- •Sign the informed consent form
排除标准
- •Donors aged under 18 years
- •Donor kidneys classified as Maastricht category I or II
- •Contraindications to radial artery catheterization
- •Cardiac dysfunction (exercise tolerance less than 4 METS)
- •Severe liver dysfunction (Child Pugh C-grade)
- •Respiratory diseases with tidal volume intolerance exceeding 8ml/kg
- •Severe arrhythmias, including atrial fibrillation, frequent atrial or ventricular premature beats, moderate or severe aortic and mitral regurgitation
- •Double-kidney transplantations
- •Simultaneous organ or additional surgeries during kidney transplantations
- •Repeat kidney transplantations
- •Concurrent participation in other clinical trials
- •Patients deemed ineligible by researchers
研究组 & 干预措施
Goal-Directed Fluid Therapy (GDFT) group
Following anesthesia induction, patients will be connected to the FlowTrac/Vigileo monitoring system to facilitate the recording of pertinent hemodynamic parameters, including stroke volume variation (SVV), stroke volume, and cardiac output. Then, Norepinephrine Infusion Combined with Goal-directed Fluid Therapy will be administered. Efforts are made to sustain a mean arterial pressure (MAP) of ≥ 80 mmHg.
干预措施: Goal-Directed Fluid Therapy (GDFT) (Drug)
Regular Fluid Therapy group
Patients will not undergo monitoring with the FlowTrac/Vigileo system throughout the whole procedure. Anesthesiologists will rely on their clinical expertise and intraoperative circulatory hemodynamic assessment to regulate fluid infusion rates and administer medications as necessary to sustain a mean arterial pressure (MAP) of ≥ 80 mmHg until the conclusion of the surgical procedure.
干预措施: Regular Fluid Therapy (Drug)
结局指标
主要结局
The incidence of delayed graft function (DGF)
时间窗: Patients will be followed from postoperative day 1 to 7.
The need for dialytic intervention within the initial week post-transplantation
次要结局
- The area under the curve of serum creatinine levels from postoperative day 1 to 7(Patients will be followed from postoperative day 1 to 7.)
- Number of dialysis sessions during postoperative hospitalization(Patients will be followed from surgery completion to discharge，an average of 20 days.)
- Duration of DGF(Patients will be followed from surgery completion to the last dialysis up to 84 days post-surgery.)
- Total urine output on the second postoperative day(Patients will be followed on the second postoperative day.)
- Duration of intensive care unit (ICU) stay(Patients will be followed during Intensive care unit (ICU) stay, an average of 2 days.)
- Length of hospitalization(Patients will be followed from hospitalization to discharge, an average of 20 days.)
- Incidence of readmission within 30 days post-discharge(Patients will be followed from discharge to 30 days after discharge.)