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Tryptophan

Clinical trials investigating “Tryptophan” are listed in the source data, but the provided records mainly describe studies of transplant care, nutrition support, and cardioplegia rather than a direct Tryptophan trial. This article summarizes the trial designs, target populations, phases, and outcomes being measured in the available records. It focuses on safety, effectiveness, and clinical recovery in surgical, transplant, and dialysis patients.

Table of Contents

Trial overview

The provided trial records do not describe a direct clinical trial of Tryptophan. Instead, they list interventional studies in heart surgery, organ transplantation, hemodialysis, and nutrition support.[1][2][3]

These studies are designed to compare two treatment strategies, often to see whether one is as good as, or safer than, another.[1][4]

Target populations

One trial studies adults having major cardiac surgery with extracorporeal circulation, which means surgery using a heart-lung machine.[1]

Two trials focus on children: one in pediatric heart transplantation and one in children with congenital heart malformation, which means a heart problem present at birth.[2][5]

Other trials include people undergoing liver, kidney, or kidney-pancreas transplantation, patients after oesophagectomy, patients after major emergency abdominal surgery, and adults on chronic hemodialysis.[3][6][7][8]

Study phases and designs

The trial list includes both Phase 2 and Phase 3 studies.[1][2][3]

Phase 2 studies in the list are the pediatric heart transplantation study and the pediatric congenital heart surgery study, and both are focused on safety and early performance signals.[2][5]

Most of the remaining studies are Phase 3 trials, which usually compare treatments in larger groups and look for stronger evidence about effect and safety.[1][3][4]

Several studies are described as randomized and single-blind, meaning treatment assignment is by chance and one side of the study does not know which treatment is given.[2][5][4]

Main endpoints being measured

The heart surgery trial measures a combined outcome of death, perioperative AMI, low cardiac output needing ionotropics, and AKIN-III acute kidney failure at 90 days.[1]

Here, AMI means acute myocardial infarction, or heart attack, and AKIN-III means severe acute kidney injury.[1]

The pediatric heart transplantation study measures safety through continuous adverse event reporting for up to 3 months.[2]

The liver transplantation study measures the area under the curve of GPT, also called ALT, during the first 7 days after transplantation.[3]

The pediatric congenital heart surgery study measures safety through adverse event reporting up to 30 days after surgery and heart muscle protection through CK-MB levels up to day 7 or discharge.[5]

The hemodialysis study measures the difference in myofibrillar fractional synthetic rate during one week, which is a marker of muscle protein building.[4]

The oesophagectomy study measures muscle size on CT scan before and 10 days after surgery.[6]

The emergency abdominal surgery study measures the rate of infectious complications during the hospital stay.[7]

The kidney, liver, and kidney-pancreas transplantation study measures delayed graft function for kidney transplants and AUC of GPT (ALT) for liver transplants over the first 7 days.[8]

What the trials compare

The cardiac surgery trial compares Custodiol crystalloid cardioplegia with Buckberg hematic cardioplegia, with a goal of showing that Custodiol is not worse than the blood-based method by a clinically important amount.[1]

The pediatric heart transplantation trial compares Custodiol with Custodiol-N for organ perfusion, which means preserving the organ before transplant.[2]

The liver transplantation study also compares Custodiol with Custodiol-N and looks at liver injury after transplant through ALT results.[3]

The hemodialysis study looks at the effect of IDPN, which is intradialytic parenteral nutrition, meaning nutrition given through a vein during dialysis.[4]

The pediatric congenital heart surgery study compares Custodiol-N with Custodiol for cardioplegia, and the trial is focused on safety and heart muscle protection.[5]

The transplantation study covering kidney, liver, and kidney-pancreas surgery compares Custodiol-N with Custodiol for graft preservation, meaning keeping the transplanted organ in good condition.[8]

Study status and enrollment

Most of the listed studies are Authorised, which means they are approved to run.[1][2][3][4][6][7][8]

One pediatric cardiac surgery trial is Suspended, which means it has been paused.[5]

Enrollment ranges from 15 participants in the small pediatric heart transplantation study to 600 participants in the large cardiac surgery trial.[2][1]

This mix of small and large studies suggests that the research questions range from early safety testing to broader comparison of treatment results in real patient groups.[2][8]

Trial ID Phase Condition studied Status Enrollment
2024-511948-42-00 Phase 3 Cardiovascular surgery Authorised 600
2023-510492-57-00 Phase 2 Heart transplantation in children Authorised 15
2024-518174-13-00 Phase 3 Liver transplantation Authorised 200
2025-522111-42-02 Phase 3 Muscle protein turnover, hemodialysis Authorised 20
2024-511517-38-00 Phase 2 Congenital heart malformation in children Suspended 100
2023-507649-27-00 Phase 3 Oesophagectomy Authorised 38
2023-505378-14-00 Phase 3 Major emergency abdominal surgery Authorised 342
2024-512444-29-00 Phase 3 Kidney, liver, or kidney-pancreas transplantation Authorised 362

FAQ

  • What kinds of studies are listed in the available trial data? The records describe interventional studies in surgery, organ transplantation, and nutrition support. Most are phase 2 or phase 3 trials that compare two treatment approaches and measure safety or recovery outcomes.
  • Who can take part in these trials? The target groups include children having heart transplantation, children with congenital heart malformation, adults having major cardiac surgery, people having liver, kidney, or pancreas transplantation, patients after oesophagectomy, and patients on chronic hemodialysis. Each trial has its own population.
  • What phases are shown in the trial list? The trials are mainly phase 2 and phase 3 studies. Phase 2 trials usually focus on safety, while phase 3 trials compare how well different treatments work in larger groups.
  • What outcomes are being measured? The outcomes include safety events, survival-related events, kidney or liver function, muscle protein synthesis, infection rates, and markers of heart muscle injury. Some studies also measure changes over time, such as during the first 7 days or up to 90 days after treatment.
  • Is Tryptophan the main treatment in these records? No direct Tryptophan-focused trial is described in the provided records. The listed studies mainly evaluate transplant solutions, cardioplegia, and nutrition products in specific patient groups.

Ongoing Clinical Trials on Tryptophan

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

    Recruiting

    2 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

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria

  • Study of Intradialytic Parenteral Nutrition for Muscle Protein Production in Patients on Long-term Hemodialysis Treatment

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

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

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on the Effects of Custodiol and Buckberg Cardioplegia in Patients Undergoing Major Heart Surgery with Prolonged Aortic Clamping

    Not yet recruiting

    3 1 1 1
    Investigated drugs:
    Spain

  • Study on Nutrition Methods and Muscle Loss After Esophagectomy Using SmofKabiven and Drug Combination for Patients Recovering from Esophageal Surgery

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on Early vs. Delayed Supplementary Parenteral Nutrition with SmofKabiven for Patients After Major Emergency Abdominal Surgery

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

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

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Interventional study: A trial where researchers assign a treatment or procedure and then compare results.
  • Phase 2: An early clinical trial phase that often looks at safety and first signs of benefit.
  • Phase 3: A later trial phase that compares treatments in larger patient groups.
  • Randomized: Patients are placed into study groups by chance, which helps make the comparison fair.
  • Single-blind: A study design where one side, usually the patient, does not know which treatment is given.
  • Non-inferiority: A study goal showing that one treatment is not worse than the other by more than a set amount.
  • Cardioplegia: A method used during heart surgery to protect the heart while it is stopped.
  • Organ preservation: Keeping an organ in good condition before or during transplantation.
  • AUC: Area under the curve, a way to measure a lab result over time rather than at one single point.
  • CK-MB: A blood marker that can rise when heart muscle is injured.
  • Delayed graft function: When a transplanted organ, often a kidney, does not start working right away.
  • Cachexia: Severe muscle and weight loss linked to illness.

References

  1. https://clinicaltrials.gov/study/2024-511948-42-00
  2. https://clinicaltrials.gov/study/2023-510492-57-00
  3. https://clinicaltrials.gov/study/2024-518174-13-00
  4. https://clinicaltrials.gov/study/2025-522111-42-02
  5. https://clinicaltrials.gov/study/2024-511517-38-00
  6. https://clinicaltrials.gov/study/2023-507649-27-00
  7. https://clinicaltrials.gov/study/2023-505378-14-00
  8. https://clinicaltrials.gov/study/2024-512444-29-00