Table of Contents
- Trial overview
- Studies after surgery
- Study in kidney disease
- Outcomes measured in the trials
- Who the trials are designed for
- Trial phases and status
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.[1][2][3] All three listed studies are in Phase 3 and are marked as authorised.[1][2][3]
The studies focus on patient recovery after major surgery and on muscle protection in advanced kidney disease.[1][2][3] The main idea across the trials is to see whether the studied treatment approach improves health outcomes linked to nutrition, infection, and muscle loss.[1][2][3]
Studies after surgery
One trial studies people after oesophagectomy, which is surgery to remove all or part of the esophagus.[1] This study looks at how the route of nutrition affects muscle wasting, meaning loss of muscle size.[1] 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.[1]
Another trial studies adults after major emergency abdominal surgery.[2] 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.[2] The main outcome is a reduction in infectious complications during the hospital stay.[2]
Study in kidney disease
The third trial focuses on people with chronic kidney disease, specifically stage 4 and 5 disease.[3] It studies whether ketoanalogue supplementation helps protect muscle in patients who follow a moderately low protein diet.[3] The brief summary says the trial is designed to assess the effect on sarcopenia, which means low muscle mass and weakness, at 12 months.[3]
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.[3] This gives researchers a way to see whether muscle is being preserved over time.[3]
Outcomes measured in the trials
Each trial uses a different main endpoint, which is the main result the researchers want to measure.[1][2][3] In the surgery study after oesophagectomy, the endpoint is change in muscle size on CT-scan over 10 days.[1] In the emergency abdominal surgery study, the endpoint is the rate of infectious complications during admission.[2]
In the kidney disease study, the endpoint is muscle mass index by DEXA after 12 months.[3] 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.[1][2][3]
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.[1] The second study targets adults having major emergency abdominal surgery, who may face infection risk during recovery.[2] 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.[3]
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.[1][2][3]
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.[1][2][3] Their status is authorised, so they are approved to proceed in the source data.[1][2][3]
The enrolled group sizes are 38 in the oesophagectomy study, 342 in the emergency abdominal surgery study, and 100 in the kidney disease study.[1][2][3] These numbers suggest that the studies vary from small to medium-sized research projects.[1][2][3]
