Table of contents
- Trials overview
- Study 1: LOTUS
- Study 2: Kidney outcomes in critical illness
- What the endpoints mean
- Who the trials are for
- What patients should know
Trials overview
The provided trial data include two interventional studies, which means the researchers are testing a treatment and then measuring the results in patients.[1][2]
Both studies are Phase 3 and are marked as authorised.[1][2]
The records focus on serious medical situations, including chronic hemodialysis and critical illness with kidney problems.[1][2]
Study 1: LOTUS
The first trial is called LOTUS and has the ID 2025-522111-42-02.[1]
It is a Phase 3 interventional study with an enrollment of 20 participants.[1]
The study is being done in people with chronic hemodialysis, which means patients whose blood is regularly cleaned by a dialysis machine because their kidneys do not work well enough.[1]
The brief summary says the study aims to see the effect of IDPN on muscle protein synthesis in chronic hemodialysis patients and to describe the hemodynamic effects of IDPN.[1]
The main endpoint is the difference in myofibrillar fractional synthetic rate during one week of treatment with IDPN versus control.[1]
Study 2: Kidney outcomes in critical illness
The second trial has the ID 2025-523914-10-00 and is also a Phase 3 interventional study.[2]
It includes 660 participants and focuses on metabolic acidosis, critical illness, and acute kidney injury.[2]
The brief summary says the study is investigating the effect of sodium bicarbonate on major adverse kidney events at day 90.[2]
The primary outcome is MAKE90, a combined endpoint that includes death, any kidney replacement therapy within 90 days after randomization, or persistent renal dysfunction at day 90.[2]
The intervention list includes several infusion solutions and sodium hydrogen carbonate, which shows that this study compares treatment options given by intravenous infusion.[2]
What the endpoints mean
An endpoint is the main result researchers measure to see whether a treatment helps.[1][2]
In the LOTUS study, the endpoint measures how fast muscle protein is being made, which helps researchers understand muscle building in dialysis patients.[1]
In the kidney study, the endpoint combines several serious outcomes into one measure so researchers can see whether treatment lowers the risk of major kidney problems.[2]
Who the trials are for
The LOTUS trial is for people on chronic hemodialysis, a group that often has complex nutrition and muscle health needs.[1]
The second trial is for critically ill patients who have metabolic acidosis and acute kidney injury, which are both serious conditions seen in hospitals.[2]
These trial records do not provide full eligibility rules, so the exact inclusion and exclusion criteria are not shown in the source data.[1][2]
What patients should know
The available records show that the research is still in the testing stage and is focused on specific patient groups rather than the general population.[1][2]
The data do not give detailed results yet, so these entries describe what the studies are designed to measure, not what they have already found.[1][2]
Because the source data are limited, the article can only summarize the trial aims, phases, populations, and endpoints that are listed here.[1][2]




