CUstodiol Versus RInger: whaT Is the Best Agent?

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

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.

Study Overview

• Status: Completed
• Conditions: Thoracoabdominal Aortic Aneurysms
• Intervention / Treatment: Drug: Custodiol; Drug: Enriched Ringer's lactate solution

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20132
    • San Raffaele Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Custodiol; Renal perfusion with Custodiol (cold crystalloid solution enriched with histidine-tryptophan-ketoglutarate).	Drug: Custodiol
Active Comparator: enriched Ringer's lactate solution; Renal perfusion with cold Ringer's lactate solution enriched with methylprednisolone 125 mg /L and mannitol 12.5 g /L.	Drug: Enriched Ringer's lactate solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Acute Kidney Injury	Kidney function will be assessed during hospital stay (an expected average of 2 weeks)

Collaborators and Investigators

• Sponsor: Scientific Institute San Raffaele

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): January 17, 2018
• Study Completion (Actual): January 17, 2018

Study Registration Dates

• First Submitted: December 15, 2014
• First Submitted That Met QC Criteria: December 24, 2014
• First Posted (Estimate): December 30, 2014

Study Record Updates

• Last Update Posted (Actual): May 23, 2019
• Last Update Submitted That Met QC Criteria: May 21, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: CURITIBA/9/OSR