In short
Clinical trials in this article investigate Magnesium-related study settings through organ preservation and heart surgery research. The trials compare Custodiol-N with Custodiol in patients having kidney, liver, pancreas, or heart procedures, including children. They mainly assess safety, graft function, and organ protection.
Key points
- These clinical trials investigate Magnesium-related study settings in organ preservation and pediatric heart surgery. The main populations are patients needing kidney, liver, or kidney-pancreatic transplantation, children having heart transplantation, and children with congenital heart malformation. The studies are mostly Phase 2 and Phase 3. Researchers are comparing Custodiol-N with Custodiol. The main outcomes include safety, delayed graft function, liver injury markers, and myocardial protection. One pediatric heart surgery study is suspended, while the others are authorised.
Trial overview
These studies are interventional trials, which means the research teams give study treatments and compare results between groups.
The trials compare Custodiol-N with Custodiol in organ preservation or cardiac surgery settings.
The source data do not describe Magnesium as the study drug in detail, but the article is based only on the trial records provided and their study settings.
Who is being studied
One Phase 3 study includes patients who will undergo kidney, liver, or kidney-pancreatic transplantation.
Another Phase 3 study focuses on liver transplantation patients.
A Phase 2 study is in children having heart transplantation.
Another Phase 2 study is in children with congenital heart malformation, which means a heart problem present from birth.
Study phases and design
Two trials are in Phase 3, which usually means a later stage of testing in a larger group of people.
Two trials are in Phase 2, which usually looks closely at safety and early signs of benefit.
Several trials are described as prospective and randomized, meaning they are planned in advance and assign treatments by chance to compare groups fairly.
Some studies are also single blind, which means one side in the study does not know which treatment was given.
What is being measured
The main outcome in the kidney part of the Phase 3 transplant study is delayed graft function, which means the transplanted kidney does not start working right away.
In the liver transplant studies, the main outcome is the area under the curve (AUC) of GPT (ALT) over the first 7 days after transplantation.
GPT (ALT) is a liver blood test, and the study uses repeated daily measurements to summarize liver injury over time.
The pediatric heart transplantation study measures safety by tracking adverse events for up to 3 months.
The pediatric congenital heart surgery study also measures safety through adverse event reporting, and it checks myocardial protection, which means protection of the heart muscle during surgery.
In that study, heart muscle protection is assessed by CK-MB levels, a blood marker used during the postoperative period.
Trial status and size
Three studies are currently authorised.
One pediatric Phase 2 study is suspended.
The planned enrollment ranges from 15 participants in the smallest pediatric heart transplant study to 362 participants in the largest transplant preservation study.
What these trials mean for patients
These trials are mainly trying to find out whether Custodiol-N can match or improve the results of Custodiol in surgery and transplantation settings.
For patients, the key questions are whether the transplanted organ works well, whether liver tests stay lower, and whether treatment is safe in the first days or months after surgery.
The trial records show research focused on both adult transplant care and pediatric heart-related surgery, with outcomes chosen to reflect real recovery after the operation.