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MALIC ACID

Clinical trials investigating MALIC ACID are studying its use in critically ill patients with metabolic acidosis and acute kidney injury. The main goal is to see whether treatment can improve kidney-related outcomes and overall safety in this high-risk group. The trial data here focus on adults in a hospital setting and measure effects over 90 days.

Table of contents

Trial overview

The available trial data describe one interventional study of MALIC ACID in patients with serious illness.[1] The study is designed to look at whether the treatment can improve kidney-related outcomes in people with metabolic acidosis and acute kidney injury.[1]

Who is being studied

This trial focuses on critically ill patients, meaning people who are very sick and need close hospital care.[1] The condition group includes metabolic acidosis, critical illness, and acute kidney injury.[1] The source data do not provide more detailed inclusion or exclusion rules.

Trial design and phase

The study is in Phase 3, which is a later stage of clinical research where a treatment is tested in a larger group of patients.[1] The planned enrollment is 660 participants, which suggests the researchers want enough people to better judge whether the treatment changes outcomes.[1]

What is being measured

The main outcome is major adverse kidney events (MAKE90).[1] This is a combined endpoint, which means several serious results are grouped together into one main measure.[1] It includes death, any kidney replacement therapy within 90 days after randomization, or persistent renal dysfunction at day 90.[1] Persistent renal dysfunction is defined in the trial data as a creatinine value at day 90 that is at least 200% of baseline.[1]

Treatment groups in the study

The intervention list includes MALIC ACID-related comparison with several infusion solutions, including SODIUM HYDROGEN CARBONATE, Jonosteril Infusionslösung, Elektrolyt-Infusionslösung 153, Sterofundin ISO Infusionslösung, and Ringer-Infusionslösung B. Braun.[1] The source data show that these are given by intravenous infusion, meaning through a vein.[1] The trial title specifically states that it is evaluating the clinical effectiveness of sodium bicarbonate in this patient group.[1]

What the status means

The trial status is Authorised.[1] In simple terms, this means the study has been approved to run according to the source record.[1]

The study is focused on a high-risk hospital population, and the outcome is centered on serious kidney events over a 90-day period.[1] Because the trial is Phase 3 and includes 660 participants, it is aimed at finding clearer evidence about whether the treatment helps in this setting.[1]

Trial ID Phase Condition studied Status Enrollment
2025-523914-10-00 Phase 3 Metabolic acidosis, critical illness, acute kidney injury Authorised 660

FAQ

  • What is being studied in the MALIC ACID trial? The trial is studying whether MALIC ACID-related treatment can improve outcomes in critically ill patients with metabolic acidosis and acute kidney injury. The main focus is kidney-related recovery and serious kidney events within 90 days.
  • Who can take part in this trial? The trial targets critically ill patients who have metabolic acidosis and acute kidney injury. The source data do not give more detailed eligibility rules.
  • What phase is the MALIC ACID trial? This study is in Phase 3. Phase 3 trials usually test whether a treatment works in a larger group of patients and continue to look at safety and outcomes.
  • What outcome is the trial measuring? The main outcome is major adverse kidney events, also called MAKE90. This includes death, kidney replacement therapy, or lasting kidney dysfunction by day 90.
  • What is the status of the trial? The trial is authorised. This means it has been approved to run, according to the source data.

Igangværende kliniske forsøg for MALIC ACID

  • Undersøgelse af effekten af natriumbicarbonat på alvorligt syre-base-ubalance og akut nyresvigt hos kritisk syge patienter

    Rekrutterer

    1 1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Tyskland

Ordliste

  • Critically ill: A very serious medical condition where a patient needs close monitoring and intensive hospital care.
  • Metabolic acidosis: A condition where the blood becomes too acidic. This can happen in serious illness and may affect how the body works.
  • Acute kidney injury: A sudden problem where the kidneys do not work as well as they should.
  • Phase 3: A later stage of clinical research that studies a treatment in a larger group of patients to see how well it works.
  • Interventional study: A trial where researchers give a treatment or compare treatments to study the results.
  • Primary outcome: The main result the trial is designed to measure.
  • Major adverse kidney events (MAKE90): A combined measure that includes death, need for kidney replacement therapy, or lasting kidney problems within 90 days.
  • Kidney replacement therapy (KRT): Treatment that helps do the work of the kidneys, such as dialysis.
  • Persistent renal dysfunction: Ongoing kidney problems that have not returned to baseline, or starting level, by the end of follow-up.
  • Baseline: The starting measurement taken before the trial treatment or follow-up begins.

Referencer

  1. https://clinicaltrials.gov/study/2025-523914-10-00