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Trial record 2 of 3 for:    "Aortic Disease" | "Prednisolone"

CUstodiol Versus RInger: whaT Is the Best Agent?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02327611
Recruitment Status : Completed
First Posted : December 30, 2014
Last Update Posted : May 23, 2019
Information provided by (Responsible Party):
yamume tshomba, Scientific Institute San Raffaele

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

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Study Type : Interventional  (Clinical Trial)
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 : February 2015
Actual Primary Completion Date : January 17, 2018
Actual Study Completion Date : January 17, 2018

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

Primary Outcome Measures :
  1. Acute Kidney Injury [ Time Frame: Kidney function will be assessed during hospital stay (an expected average of 2 weeks) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02327611

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San Raffaele Hospital
Milano, Italy, 20132
Sponsors and Collaborators
Scientific Institute San Raffaele

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Responsible Party: yamume tshomba, Medical Doctor Associate Professor of Vascular Surgery, Scientific Institute San Raffaele Identifier: NCT02327611     History of Changes
Other Study ID Numbers: CURITIBA/9/OSR
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Pharmaceutical Solutions