A prospective, randomized, single-blind, multicentre, phase III study on organ preservation with Custodiol-N solution compared with Custodiol® solution in organ transplantation (kidney, liver and pancreas).

Abstract

BACKGROUND:

Organ preservation before transplantation is still a challenge. Both the University of Wisconsin and Bretschneider's histidine-tryptophan-ketoglutarate (HTK; Custodiol®) solution are standard for liver, kidney and pancreas preservation. Organ preservation with both solutions is comparable; recently, however, Custodiol® solution has been modified to Custodiol-N according to the needs of today. Thus, our study was defined to study its effect in clinical transplantation.

METHODS:

Patients undergoing kidney transplantation (n = 412) (including approximately 30 combined kidney-pancreas) or liver transplantation (n = 202) receive grafts that have been cold stored in either Custodiol® or Custodiol-N to demonstrate noninferiority of Custodiol-N regarding both graft function and graft injury after transplantation.

DISCUSSION:

Preclinical data have clearly shown that Custodiol-N is superior to Custodiol® in cold static organ preservation via mechanisms including inhibition of hypoxic cell injury, cold-induced cell injury and avoidance of adverse effects during warm exposure to the solution. Further clinical safety data on Custodiol-N for cardioplegia are available. Thus, this study was designed to compare Custodiol® with Custodiol-N for the first time in a prospective, randomized, single-blinded, multicentre, phase III clinical transplantation trial.

TRIAL REGISTRATION:

Eudra-CT, 2017-002198-20. Registered on 28 November 2018.

• Authors: Daniela Kniepeiss, Philipp Houben, Philipp Stiegler, Andrea Berghold, Regina Riedl, Judith Kahn, Peter Schemmer
• Journal: Trials (Trials) Vol. 21 Issue 1 Pg. 62 (Jan 10 2020) ISSN: 1745-6215 [Electronic] England
• PMID: 31924234 (Publication Type: Clinical Trial Protocol, Journal Article)

Chemical References

• Bretschneider cardioplegic solution
• Custodiol-N solution
• Organ Preservation Solutions
• Mannitol
• Procaine
• Potassium Chloride
• Glucose

Topics

• Austria
• Clinical Trials, Phase III as Topic
• Glucose (adverse effects, therapeutic use)
• Graft Survival (drug effects)
• Humans
• Kidney Transplantation (adverse effects)
• Liver Transplantation (adverse effects)
• Mannitol (adverse effects, therapeutic use)
• Multicenter Studies as Topic
• Organ Preservation (adverse effects)
• Organ Preservation Solutions (adverse effects, therapeutic use)
• Pancreas Transplantation (adverse effects)
• Potassium Chloride (adverse effects, therapeutic use)
• Procaine (adverse effects, therapeutic use)
• Prospective Studies
• Randomized Controlled Trials as Topic
• Single-Blind Method
• Time Factors
• Tissue and Organ Harvesting (adverse effects)
• Treatment Outcome