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临床试验/NCT02327611
NCT02327611已完成4 期

CUstodiol Versus RInger: whaT Is the Best Agent? A Randomized Double Blind Trial.

Scientific Institute San Raffaele1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Acute Kidney Injury

研究概览

简要总结

Postoperative renal failure is the most significant risk factor for early mortality after elective surgical repair of thoracoabdominal aortic aneurysms (TAAAs).

To prevent damages related to kidney ischemia during aortic crossclamping and TAAA repair, the most recent guidelines recommend the use of cold crystalloid or blood perfusion. Since the most studied crystalloid solution is the Ringer's lactate solution, this can be considered the standard of care for evaluating the effectiveness of other substrates.

An histidine-tryptophan-ketoglutarate enriched crystalloid solution named Custodiol (Dr. Franz Kohler Chemie GmbH, Bensheim, Germany) is currently used for organ preservation during transplantation and for cardioplegia during open-heart surgery in most EU countries. This solution may provide a better grade of renal protection to ischemic damage than the standard crystalloid solutions.

A recent observational study published by our group suggested a lower incidence of postoperative renal kidney injury in patients undergoing open TAAA surgical repair using renal perfusion with Custodiol, as compared to those perfused with an enriched Ringer's lactate solution.

Objective of this study is the confirmation of the promising findings about the effectiveness of renal perfusion with Custodiol during repair of TAAA compared with other crystalloid.

The study will be a prospective, single-center, randomized, double-blind, controlled trial, investigating Acute Kidney Injury in patients undergoing TAAA open repair using Custodiol renal perfusion versus an enriched Ringer's lactate solution. It is expected to enroll adult patients undergoing elective TAAA open repair. Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

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
Quadruple (Participant, Care Provider, Investigator, 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

入选标准

  • Ability to provide written informed consent; Patient undergoing open surgical repair of TAAA requiring renal perfusion.

排除标准

  • Patients who have participated to experimental trials during the previous 3 months
  • Intervention under emergency / urgency
  • Patient uncooperative and / or affected by mental disease
  • Allergy or intolerance to the study drug
  • Patient under renal replacement treatment (dialysis) before surgery
  • Pregnant or breast-feeding women

研究组 & 干预措施

Custodiol

Experimental

Renal perfusion with Custodiol (cold crystalloid solution enriched with histidine-tryptophan-ketoglutarate).

干预措施: Custodiol (Drug)

enriched Ringer's lactate solution

Active Comparator

Renal perfusion with cold Ringer's lactate solution enriched with methylprednisolone 125 mg /L and mannitol 12.5 g /L.

干预措施: Enriched Ringer's lactate solution (Drug)

结局指标

主要结局

Acute Kidney Injury

时间窗: Kidney function will be assessed during hospital stay (an expected average of 2 weeks)

次要结局

未报告次要终点

研究者

发起方
Scientific Institute San Raffaele
申办方类型
Other
责任方
Principal Investigator
主要研究者

yamume tshomba

Medical Doctor Associate Professor of Vascular Surgery

Scientific Institute San Raffaele

研究点 (1)

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