In short
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.
Key points
- The available records describe several clinical trials, but they mainly focus on surgery, organ transplantation, and nutrition support rather than a direct Tryptophan study. Most trials are phase 3, with a smaller number of phase 2 studies. The target groups include children with heart disease, transplant patients, people after major surgery, and patients on hemodialysis. The studies are comparing treatment strategies such as organ preservation solutions, cardioplegia methods, and nutrition plans. Main outcomes include safety, organ function, infection rates, muscle loss, and signs of heart or kidney injury. One study is suspended, while the others are authorised.
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.
These studies are designed to compare two treatment strategies, often to see whether one is as good as, or safer than, another.
Target populations
One trial studies adults having major cardiac surgery with extracorporeal circulation, which means surgery using a heart-lung machine.
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.
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.
Study phases and designs
The trial list includes both Phase 2 and Phase 3 studies.
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.
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.
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.
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.
Here, AMI means acute myocardial infarction, or heart attack, and AKIN-III means severe acute kidney injury.
The pediatric heart transplantation study measures safety through continuous adverse event reporting for up to 3 months.
The liver transplantation study measures the area under the curve of GPT, also called ALT, during the first 7 days after transplantation.
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.
The hemodialysis study measures the difference in myofibrillar fractional synthetic rate during one week, which is a marker of muscle protein building.
The oesophagectomy study measures muscle size on CT scan before and 10 days after surgery.
The emergency abdominal surgery study measures the rate of infectious complications during the hospital stay.
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.
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.
The pediatric heart transplantation trial compares Custodiol with Custodiol-N for organ perfusion, which means preserving the organ before transplant.
The liver transplantation study also compares Custodiol with Custodiol-N and looks at liver injury after transplant through ALT results.
The hemodialysis study looks at the effect of IDPN, which is intradialytic parenteral nutrition, meaning nutrition given through a vein during dialysis.
The pediatric congenital heart surgery study compares Custodiol-N with Custodiol for cardioplegia, and the trial is focused on safety and heart muscle protection.
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.
Study status and enrollment
Most of the listed studies are Authorised, which means they are approved to run.
One pediatric cardiac surgery trial is Suspended, which means it has been paused.
Enrollment ranges from 15 participants in the small pediatric heart transplantation study to 600 participants in the large cardiac surgery trial.
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.