In short
Clinical trials investigating Lysine Acetate are studying how it is used in different surgical and kidney disease settings. These trials look at outcomes such as muscle loss, infections, and muscle mass, and they mainly include adults after major surgery or with advanced chronic kidney disease.
Key points
- Clinical trials linked to Lysine Acetate are studying recovery after major surgery and outcomes in advanced kidney disease. All listed studies are Phase 3 and are authorised. The target groups include adults after oesophagectomy, adults after major emergency abdominal surgery, and patients with stage 4 or 5 chronic kidney disease. The main outcomes are muscle size, infection rates, and muscle mass over time. These trials are focused on whether the study treatment can help protect muscle and improve recovery.
Trial overview
The available clinical trials for Lysine Acetate are all interventional studies, which means researchers are testing a treatment in people and measuring the results. All three listed studies are in Phase 3 and are marked as authorised.
The studies focus on patient recovery after major surgery and on muscle protection in advanced kidney disease. The main idea across the trials is to see whether the studied treatment approach improves health outcomes linked to nutrition, infection, and muscle loss.
Studies after surgery
One trial studies people after oesophagectomy, which is surgery to remove all or part of the esophagus. This study looks at how the route of nutrition affects muscle wasting, meaning loss of muscle size. The primary outcome is the mean difference in muscle size on CT-scan from before surgery to 10 days after oesophagostomy, which is used here to track short-term change in muscle size.
Another trial studies adults after major emergency abdominal surgery. This study compares early versus postponed supplementary parenteral nutrition, which means nutrition given through a vein, to see whether the timing changes the risk of hospital infections. The main outcome is a reduction in infectious complications during the hospital stay.
Study in kidney disease
The third trial focuses on people with chronic kidney disease, specifically stage 4 and 5 disease. It studies whether ketoanalogue supplementation helps protect muscle in patients who follow a moderately low protein diet. The brief summary says the trial is designed to assess the effect on sarcopenia, which means low muscle mass and weakness, at 12 months.
The main outcome is the muscle mass index measured by DEXA at 12 months, using appendicular lean mass, which is the lean muscle in the arms and legs. This gives researchers a way to see whether muscle is being preserved over time.
Outcomes measured in the trials
Each trial uses a different main endpoint, which is the main result the researchers want to measure. In the surgery study after oesophagectomy, the endpoint is change in muscle size on CT-scan over 10 days. In the emergency abdominal surgery study, the endpoint is the rate of infectious complications during admission.
In the kidney disease study, the endpoint is muscle mass index by DEXA after 12 months. These outcomes show that the trials are not only looking at treatment use, but also at real health results such as muscle preservation and infection prevention.
Who the trials are designed for
The first study targets patients after oesophagectomy, a group that may be at risk of cachexia, which is severe weight and muscle loss during illness. The second study targets adults having major emergency abdominal surgery, who may face infection risk during recovery. The third study targets patients with stage 4 or 5 chronic kidney disease and a dietary protein intake between 0.6 and 0.8 g/kg/day.
Together, these trials show that the research is aimed at people with serious medical conditions where nutrition and muscle health are important parts of recovery.
Trial phases and status
All three studies are listed as Phase 3 trials, which usually means a treatment is being tested in larger patient groups to better understand its benefits and key outcomes. Their status is authorised, so they are approved to proceed in the source data.
The enrolled group sizes are 38 in the oesophagectomy study, 342 in the emergency abdominal surgery study, and 100 in the kidney disease study. These numbers suggest that the studies vary from small to medium-sized research projects.