In short
Clinical trials investigating MALIC ACID are studying critically ill patients with metabolic acidosis and acute kidney injury. These trials aim to evaluate clinical effectiveness and kidney outcomes, especially major adverse kidney events at 90 days. The main study is a Phase 3 interventional trial in hospitalized patients.
Key points
- Clinical trials investigating MALIC ACID are focused on critically ill patients with metabolic acidosis and acute kidney injury. The provided study is a Phase 3 interventional trial with 660 planned participants. It is designed to measure whether treatment affects major adverse kidney events at 90 days. The main endpoint includes death, need for kidney replacement therapy, or lasting kidney dysfunction. The trial is currently authorised.
Trial overview
The available trial data describe one interventional study of MALIC ACID in critically ill patients with metabolic acidosis and acute kidney injury. The study title says it is evaluating the clinical effectiveness of sodium bicarbonate for these patients.
Who is being studied
The target population is patients who are seriously ill and have both metabolic acidosis and acute kidney injury. The data do not give more detailed entry rules, such as age limits or specific hospital settings.
Study design and phase
This is an interventional trial, which means researchers are testing a treatment and observing patient outcomes. It is a Phase 3 study with planned enrollment of 660 people.
The interventions listed include sodium bicarbonate and several comparison infusion solutions, such as Jonosteril Infusionslösung, Elektrolyt-Infusionslösung 153, Sterofundin ISO Infusionslösung, and Ringer-Infusionslösung B. Braun. The trial data do not explain the full comparison plan, but they show that the study is testing treatment options given by intravenous infusion.
What is being measured
The main outcome is Major adverse kidney events (MAKE90). This is a combined endpoint, meaning several important results are grouped into one measure.
MAKE90 includes death, any kidney replacement therapy within 90 days after randomization, or persistent renal dysfunction at day 90, defined as creatinine at least 200% of baseline. In simple terms, the study is checking whether treatment helps protect the kidneys and improve survival over the first 90 days.
Trial status and size
The trial status is listed as Authorised. The planned enrollment is 660 participants, which suggests a fairly large study for a Phase 3 trial.
Because only one trial record is provided, the current evidence here is limited to this single study description.