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N-Acetylhistidine

This article discusses clinical trials investigating the use of N-Acetylhistidine, a component of the organ preservation solution Custodiol-N, in various transplantation procedures. These trials aim to compare the effectiveness and safety of Custodiol-N with standard solutions for preserving organs during transplantation, focusing on heart, liver, kidney, and pancreas transplants in both adult and pediatric patients.

Table of Contents

What is N-Acetylhistidine?

N-Acetylhistidine is a chemical compound that is being studied for its potential benefits in organ preservation during transplantation procedures. It is a modified form of the amino acid histidine, with an acetyl group attached to it. This compound is one of the key ingredients in a new organ preservation solution called Custodiol-N.[1]

Custodiol-N: A New Organ Preservation Solution

Custodiol-N is an advanced organ preservation solution that contains N-acetylhistidine along with several other components. This solution is designed to protect organs during the transplantation process, from the time they are removed from the donor until they are implanted in the recipient. Custodiol-N is being compared to the standard Custodiol solution in various clinical trials to assess its effectiveness and safety.[2]

Uses of N-Acetylhistidine in Organ Transplantation

N-Acetylhistidine, as part of the Custodiol-N solution, is being investigated for use in several types of organ transplantation:

  • Heart transplantation: Studies are examining its use in pediatric heart transplants to see if it can improve outcomes for children receiving new hearts.[1]
  • Liver transplantation: Research is ongoing to determine if Custodiol-N can better preserve liver function during transplantation.[3]
  • Kidney transplantation: Clinical trials are assessing the effectiveness of Custodiol-N in preserving kidneys for transplant.[4]
  • Pancreas transplantation: The solution is also being studied for its potential benefits in pancreas preservation during transplant procedures.[4]

Potential Benefits of N-Acetylhistidine

While research is still ongoing, N-acetylhistidine as part of the Custodiol-N solution may offer several potential benefits:

  • Improved organ preservation: It may help protect organs from damage during the transplantation process, potentially leading to better function after transplant.[2]
  • Reduced complications: By potentially improving organ preservation, it might help reduce post-transplant complications and improve overall outcomes.[3]
  • Extended preservation time: There is hope that Custodiol-N might allow for longer preservation times, which could improve logistics for organ transplantation.[4]

Ongoing Research and Clinical Trials

Several clinical trials are currently underway to evaluate the safety and effectiveness of Custodiol-N, which contains N-acetylhistidine:

  • A study comparing Custodiol-N to standard Custodiol in pediatric heart transplantation.[1]
  • A trial examining the use of Custodiol-N in liver transplantation, focusing on markers of liver function and complications after transplant.[3]
  • A large study comparing Custodiol-N to Custodiol in kidney, liver, and pancreas transplantation.[4]

These studies are measuring various outcomes, including organ function, complication rates, and patient survival, to determine if Custodiol-N offers advantages over current preservation methods.

Conclusion

N-Acetylhistidine, as a component of the Custodiol-N organ preservation solution, shows promise in improving outcomes for organ transplant recipients. While research is still ongoing, early studies suggest that it may help better protect organs during the transplantation process. As clinical trials progress, we will learn more about the potential benefits and any possible risks associated with this new preservation solution. Patients awaiting organ transplants or those interested in transplant medicine should stay informed about these developments, as they may lead to improved transplant procedures in the future.

Trial Focus Patient Population Primary Objectives Key Endpoints
Heart transplantation in children Children from birth to less than 18 years Safety assessment and myocardial protection Adverse events, CK-MB levels, vital parameters
Cardiac surgery for congenital heart defects in children Children from birth to less than 18 years Safety assessment and myocardial protection Adverse events, CK-MB levels, hemodynamics
Kidney, liver, and pancreas transplantation Adult patients (≥18 years) Graft function and injury assessment Delayed graft function, liver enzyme levels, insulin requirements
Liver transplantation Adult patients (≥18 years) Liver function and injury assessment ALT levels, LDH peaks, bilirubin, INR

FAQ

  • What is N-Acetylhistidine and how is it used in organ transplantation? N-Acetylhistidine is a component of Custodiol-N, an organ preservation solution used to protect organs during transplantation procedures. It is being studied as part of a new formulation to potentially improve organ preservation compared to standard solutions.
  • What types of transplants are being studied in these clinical trials? The clinical trials are investigating the use of Custodiol-N in heart transplants for children, liver transplants, and combined kidney and pancreas transplants in adults.
  • How do these trials compare Custodiol-N to other solutions? The trials compare Custodiol-N to a standard solution called Custodiol. They evaluate factors such as organ function, injury markers, and patient outcomes to determine if Custodiol-N is as effective or potentially better than the standard solution.
  • What are the main objectives of these clinical trials? The main objectives include assessing the safety of Custodiol-N, evaluating organ function after transplantation, measuring levels of injury markers, and comparing outcomes such as graft survival and complication rates between Custodiol-N and standard solutions.
  • Who can participate in these clinical trials? Participants include children undergoing heart transplants, adults receiving liver transplants, and patients undergoing kidney or combined kidney-pancreas transplants. Specific age ranges and other criteria vary depending on the particular study.

Ongoing Clinical Trials on N-Acetylhistidine

  • Study comparing Custodiol-N and Custodiol organ preservation solutions for heart transplantation in children

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Organ Preservation in Kidney, Liver, and Pancreas Transplants Using Custodiol-N Solution Compared to a Drug Combination for Transplant Patients

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria

  • Study Comparing Custodiol-N and Custodiol for Heart Surgery in Children with Congenital Heart Defects

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Liver Transplantation: Comparing Custodiol-N Solution with a Drug Combination for Organ Preservation in Patients Undergoing Liver Transplant Surgery

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • N-Acetylhistidine: A chemical compound that is a component of the organ preservation solution Custodiol-N, being studied for its potential benefits in protecting organs during transplantation procedures.
  • Custodiol-N: An organ preservation solution containing N-Acetylhistidine and other components, designed to protect organs during transplantation and being compared to standard solutions in clinical trials.
  • Organ preservation solution: A special fluid used to protect organs when they are removed from a donor and transported to a recipient during transplantation procedures.
  • Cardioplegia: A technique used to stop the heart temporarily during surgery, often involving the use of preservation solutions to protect the heart muscle.
  • Graft survival: The continued functioning of a transplanted organ in the recipient's body after the transplantation procedure.
  • Delayed graft function: A complication in organ transplantation where the transplanted organ does not function properly immediately after the procedure.
  • Extended criteria donors (ECD): Organ donors who may be older or have certain medical conditions, but whose organs are still considered suitable for transplantation under specific circumstances.
  • Donation after circulatory death (DCD): A type of organ donation that occurs after the heart has stopped beating, as opposed to donation after brain death.
  • Area under the curve (AUC): A statistical measure used to analyze the levels of certain substances in the blood over time, often used to assess organ function or drug effectiveness.
  • Creatinine kinase (CK-MB): An enzyme found in heart muscle cells, used as a marker to detect heart muscle damage.
  • Alanine aminotransferase (ALT): An enzyme found primarily in the liver, used as a marker of liver health and function in blood tests.
  • Bilirubin: A yellow compound produced when red blood cells break down, used as a marker of liver function in blood tests.
  • International normalized ratio (INR): A standardized measurement of blood clotting time, often used to assess liver function in transplant patients.
  • Cholangitis: Inflammation of the bile ducts, which can be a complication after liver transplantation.

References

  1. http://clinicaltrials.eu/trial/study-comparing-custodiol-n-and-custodiol-for-heart-transplantation-in-children/
  2. http://clinicaltrials.eu/trial/study-comparing-custodiol-n-and-custodiol-for-heart-surgery-in-children-with-congenital-heart-defects/
  3. http://clinicaltrials.eu/trial/study-on-liver-transplantation-comparing-custodiol-n-solution-with-a-drug-combination-for-organ-preservation-in-patients-undergoing-liver-transplant-surgery/
  4. http://clinicaltrials.eu/trial/study-on-organ-preservation-in-kidney-liver-and-pancreas-transplants-using-custodiol-n-solution-compared-to-a-drug-combination-for-transplant-patients/