CUstodiol Versus RInger: whaT Is the Best Agent?

• Sponsor: Scientific Institute San Raffaele (Other)
• Overall Status: Completed
• CT.gov ID: NCT02327611
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Duration (Months): 35.5
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Thoracoabdominal Aortic Aneurysms	Drug: Custodiol; Drug: Enriched Ringer's lactate solution	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: CUstodiol Versus RInger: whaT Is the Best Agent? A Randomized Double Blind Trial.
• Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Jan 17, 2018
• Actual Study Completion Date: Jan 17, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Acute Kidney Injury [Kidney function will be assessed during hospital stay (an expected average of 2 weeks)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Raffaele Hospital	Milano		Italy	20132

Sponsors and Collaborators

• Scientific Institute San Raffaele

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: yamume tshomba, Medical Doctor Associate Professor of Vascular Surgery, Scientific Institute San Raffaele
• ClinicalTrials.gov Identifier: NCT02327611
• Other Study ID Numbers: CURITIBA/9/OSR
• First Posted: Dec 30, 2014
• Last Update Posted: May 23, 2019
• Last Verified: May 1, 2019

• Additional relevant MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic

Study Results

No Results Posted as of May 23, 2019