CUstodiol Versus RInger: whaT Is the Best Agent?

NCT02327611 | Completed Phase 4

• 1 other identifier: CURITIBA/9/OSR
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracoabdominal Aortic Aneurysms

Outcome Measures

Primary Outcomes (1)

• Acute Kidney Injury

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

Study Arms (2)

Custodiol

EXPERIMENTAL

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

Drug: Custodiol

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.

Drug: Enriched Ringer's lactate solution

Interventions

Custodiol DRUG

Custodiol

Enriched Ringer's lactate solution DRUG

enriched Ringer's lactate solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scientific Institute San Raffaele: lead

Study Sites (1)

San Raffaele Hospital

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor Associate Professor of Vascular Surgery

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 30, 2014
• Study Start: February 1, 2015
• Primary Completion: January 17, 2018
• Study Completion: January 17, 2018
• Last Updated: May 23, 2019

Record last verified: 2019-05

Locations

IT (1)