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The Impact of Intraoperative Diuretic Use on Delayed Graft Function Following Deceased Donor Renal Transplantation

A Pilot Randomized, Surgeon-blinded, Trial of Intraoperative Furosemide Versus Mannitol Among Deceased Donor Kidney Transplant Recipients

Delayed graft function, defined as the need for dialysis within seven days of kidney transplantation, is a common complication affecting deceased-donor kidney transplant recipients. It is associated with prolonged hospitalization, increased healthcare costs, higher rates of acute rejection, and poorer long-term graft survival. Intraoperative diuretics are routinely administered during kidney transplant surgery to promote early urine output and protect the kidney from injury during reperfusion. The two most commonly used agents are furosemide and mannitol. Despite decades of clinical use, no prospective randomized trial has directly compared these two medications, and practice remains highly variable across centres and individual surgeons. This single-centre, prospective, randomized, surgeon-blinded pilot trial will enroll 240 deceased-donor kidney transplant recipients at London Health Sciences Centre. Participants will be randomized in a 1:1 ratio, stratified by donor type, to receive either intraoperative furosemide or intraoperative mannitol. The primary feasibility outcomes include recruitment rate. The primary clinical outcome is the incidence of delayed graft function. Secondary outcomes include serum creatinine trajectory, urine output, dialysis requirements, perioperative complications, length of stay, and one-year graft and patient survival. This pilot trial will provide feasibility data and effect-size estimates necessary to inform the design of a future definitive multicentre randomized controlled trial.

研究概览

详细说明

Kidney transplantation has been the treatment of choice for end-stage renal disease for over six decades, yet delayed graft function (DGF) remains one of the most common and clinically significant complications of deceased-donor kidney transplantation. Defined as the requirement for at least one session of dialysis within the first seven days following transplantation, DGF affects 20-40% of deceased-donor kidney transplant recipients depending on the donor population and centre. DGF is associated with prolonged hospitalization, increased healthcare costs, a 1.4- to 2-fold increase in acute rejection risk, and inferior long-term graft survival. The pathophysiology centres on ischemia-reperfusion injury (IRI), which causes acute tubular necrosis, endothelial dysfunction, microvascular thrombosis, and upregulation of allograft immunogenicity through increased expression of MHC molecules and damage-associated molecular patterns. Donor type significantly influences DGF risk: donation after circulatory death (DCD) organs carry the highest historic rates due to sustained hypoperfusion and anaerobic metabolism during the agonal phase, while donation after neurological death (NDD) organs are affected by systemic inflammatory responses driven by loss of sympathetic regulation. Intraoperative diuretics, furosemide and mannitol, have been used for decades during reperfusion to enhance early urine output and mitigate IRI. Furosemide, a loop diuretic, inhibits the NKCC2 co-transporter in the thick ascending limb, reducing tubular metabolic oxygen demand, promoting tubular flushing, and stimulating renal prostaglandin-mediated vasodilation. Mannitol, an osmotic diuretic, maintains high tubular flow rates, reduces tubular cell swelling, acts as a hydroxyl radical scavenger, and promotes intrarenal vasodilation through prostaglandin and natriuretic peptide release. Despite these plausible mechanisms, the evidence supporting either agent remains weak. A comprehensive review by Sandal et al. (2018) found that the evidence supporting loop diuretics in preventing DGF was poor, with no data on patient survival identified. Schnuelle and van der Woude similarly concluded that loop diuretics had not been shown to affect DGF rates or improve outcomes. For mannitol, while van Valenberg et al. described its intraoperative use as "indispensable" based on early trial data, and a systematic review by van de Laar et al. (2021) suggested lower rates of DGF with mannitol use, that review emphasized significant limitations in evidence quality and heterogeneity. A randomized trial by Reiterer et al. evaluating mannitol versus placebo in 34 deceased-donor recipients found no significant effect on oxidation-reduction potential. A preclinical study by Bipat et al. demonstrated that mannitol preserved diuresis and creatinine clearance in a rabbit model of hypoxic kidneys, providing mechanistic support but not clinical confirmation. Current clinical practice is highly heterogeneous. A UK survey of 40 transplant surgeons from 18 centres revealed that 13 used no intraoperative diuretics, 10 used mannitol alone, 6 used furosemide alone, and 11 used a combination, underscoring the complete lack of consensus. A Canadian survey similarly demonstrated wide variation in practice patterns across transplant centres. Retrospective data from the investigators' centre suggest DGF rates of approximately 30% with furosemide and 22% with mannitol, but these non-randomized data preclude definitive conclusions. The existing literature is limited by small sample sizes, retrospective designs, inconsistent dosing protocols, heterogeneous patient populations, and the absence of standardized outcome definitions. No adequately powered, prospective, randomized trial has compared furosemide head-to-head against mannitol. Multiple reviews have concluded that well designed prospective randomized data are needed. This pilot trial addresses that evidence gap by providing the first direct, randomized, blinded comparison of these two agents with standardized dosing and timing, generating feasibility data, effect-size estimates, and operational infrastructure to support a future definitive multicentre trial.

研究类型

介入性

注册 (估计的)

160

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Ontario
      • London、Ontario、加拿大、N6A 5A5
        • 招聘中
        • University Hospital - London Health Sciences Centre
        • 接触:
        • 首席研究员:
          • Dr. Alp Sener, MD, PhD
      • London、Ontario、加拿大、n6a 5a5
        • 尚未招聘
        • London Health Sciences Centre
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Age >18 years;
  2. Patient is scheduled to receive a deceased-donor kidney transplant (including both NDD and DCD donors)
  3. Patient is willing and able to provide written and informed consent, or a substitute decision maker (SDM) is available to sign on the patient's behalf

Exclusion Criteria:

  1. Patient is receiving another organ at the time of their kidney transplant (e.g., simultaneous kidney-pancreas or kidney-liver)
  2. Known allergy or contraindication to mannitol or furosemide
  3. Inability to provide informed consent
  4. Pediatric recipients (<18 years of age)
  5. Previously enrolled in this clinical trial

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Furosemide
In the Furosemide arm, 80 mg IV will be administered at 10-15 minutes prior to reperfusion of the transplanted kidney.
Furosemide is a potent loop diuretic that inhibits the sodium-potassium-2-chloride (Na+/K+/2Cl-) co-transporter (NKCC2) on the luminal surface of the thick ascending limb of the loop of Henle. By blocking this transporter, furosemide reduces sodium reabsorption, increases sodium and water delivery to the distal nephron, and produces a brisk natriuresis and diuresis. In participants randomized to the Furosemide arm, 80 mg IV will be administered at 10-15 minutes prior to reperfusion of the transplanted kidney.
有源比较器:Mannitol
In the Mannitol arm, mannitol 0.5 g/kg IV will be administered at 10-15 minutes prior to reperfusion of the transplanted kidney.
Mannitol is a six-carbon sugar alcohol that is metabolically inert, freely filtered by the glomerulus, and largely unabsorbed by the renal tubules. It remains confined to the extracellular space and is excreted unchanged in the urine. As an osmotic diuretic, mannitol increases the osmolality of the glomerular filtrate, which opposes water reabsorption along the length of the nephron and produces dilute urine. In patients randomized to the Mannitol arm, mannitol 0.5 g/kg IV will be administered at 10-15 minutes prior to reperfusion of the transplanted kidney.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Recruitment rate
大体时间:From enrollment to the end of the study (1 year)
Proportion of eligible patients who were approached and consented to enroll. Recruitment rate = number enrolled ÷ number of eligible patients screened. Reported as a percentage.
From enrollment to the end of the study (1 year)
Consent Rate
大体时间:From enrollment to the end of the study (1 year).
Consent rate = number who consented ÷ number approached. Reported as a percentage.
From enrollment to the end of the study (1 year).
Protocol Adherence
大体时间:From enrollment to end of study (1 year)
Proportion of study drug administrations (Lasix or Mannitol) delivered in accordance with the protocol, defined as correct dose given within the protocol specified time window.
From enrollment to end of study (1 year)
Data Completeness
大体时间:From enrollment to end of study (1 year)
Proportion of expected data points that were successfully collected for the key outcome variables (e.g., DGF status, serum creatinine, urine output, and other pre-specified outcomes). Calculated as the number of data points collected ÷ number of data points expected per protocol, across all enrolled participants. Reported as a percentage.
From enrollment to end of study (1 year)
Delayed Graft Function (DGF)
大体时间:From the administration of study drug until the end of post-op day 7.
Defined as the requirement for at least one session of dialysis within the first seven days following kidney transplantation. This is a dichotomous outcome assessed at day 7 post-transplant (yes/no).
From the administration of study drug until the end of post-op day 7.

次要结果测量

结果测量
措施说明
大体时间
Early graft function
大体时间:From the time of enrollment up until post op day 7.
1. To compare early graft function between groups, as measured by urine output in the first 24-72 hours, serum creatinine levels during postoperative days 1-7.
From the time of enrollment up until post op day 7.
Postoperative dialysis requirement
大体时间:Post-op day 0 until the end of enrollment (1 year)
2. To compare postoperative dialysis requirements, including number and duration of dialysis sessions.
Post-op day 0 until the end of enrollment (1 year)
Post-operative Outcomes
大体时间:Post-op day 0 until the end of post-op day 30
3. To evaluate the incidence of perioperative complications, including electrolyte abnormalities, hypotension requiring vasopressor support, pulmonary edema, transfusion requirements, biopsy-proven rejection, and 30-day readmission
Post-op day 0 until the end of post-op day 30
Survival
大体时间:Post-op day 0 up until post-op day 365 (1 year post enrollment)
4. To compare length of hospital stay and 1-year graft and patient survival between groups.
Post-op day 0 up until post-op day 365 (1 year post enrollment)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2028年8月1日

研究完成 (估计的)

2028年12月1日

研究注册日期

首次提交

2026年7月14日

首先提交符合 QC 标准的

2026年7月20日

首次发布 (实际的)

2026年7月24日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月15日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data are not currently planned to be shared with researchers outside the study team. Any future sharing of deidentified data would require approval from the research ethics board and all applicable institutional and privacy approvals.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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