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NCT Number: NCT02327611

CUstodiol Versus RInger: whaT Is the Best Agent?

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

San Raffaele Hospital

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Custodiol

Drug

Enriched Ringer's lactate solution

Drug

Primary outcomes

  1. Acute Kidney Injury

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

Sponsors and collaborators

Lead sponsor

Scientific Institute San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Dec 30, 2014
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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