Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Effect of sodium hydrogen carbonate on kidney health in critically ill patients with metabolic acidosis and acute kidney injury

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to investigate the effect of sodium hydrogen carbonate on kidney health in patients experiencing metabolic acidosis, which is a condition where there is too much acid in the body fluids, and acute kidney injury, a sudden episode of kidney failure or damage. The research also focuses on individuals suffering from critical illness. Participants will receive a treatment through an intravenous perfusion, which is a method of delivering fluids directly into a vein.

During the study, participants will be given either sodium hydrogen carbonate or a comparison solution containing electrolytes, such as sodium chloride, calcium chloride dihydrate, potassium chloride, or magnesium chloride hexahydrate. These comparison solutions include options like Jonosteril Infusionslösung, Sterofundin ISO Infusionslösung, and Ringer-Infusionslösung B. Braun. The study monitors various health outcomes over a 90-day period, including the need for kidney replacement therapy, which refers to treatments like dialysis that perform the work of the kidneys, and changes in creatinine levels, a substance in the blood used to measure how well the kidneys are functioning.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Administration of treatment

    An intravenous perfusion, which is a liquid delivered directly into a vein, is administered. the liquid given is either sodium hydrogen carbonate or one of several electrolyte solutions used for comparison.

    The total volume of the liquid provided is 2400 ml.

  2. Step 2

    Monitoring and follow-up

    The status of kidney function and overall health is monitored for a period of 90 days following the start of the study.

    Medical assessments are conducted to check for major adverse kidney events, which include death, the need for kidney replacement therapy (treatments that perform the work of the kidneys), or a significant increase in creatinine levels (a marker used to measure kidney function) at the 90-day mark.

Who can join the trial?

8 criteria

  • You must be an adult, which means you are 18 years of age or older.
  • You must be critically ill, which means you require specialized medical care in an Intensive Care Unit (a hospital department for patients with life-threatening conditions) or an Intermediate Care Unit.
  • You must have metabolic acidosis, a condition where there is too much acid in your body fluids. This is confirmed by having:
    • An arterial pH (a measurement of how acidic or alkaline your blood is) of 7.25 or lower.
    • A PaCO2 (the amount of carbon dioxide in your blood) of less than 6.5kPa.
    • A standard bicarbonate level of 20 mmol/L or less.
    • A standard base excess (a measure of how much extra base or acid is in your blood) of less than -2.
    • You must have acute kidney injury, which is a sudden episode of kidney failure or damage. Specifically, you must meet the requirements for stage 2 or 3 of the KDIGO classification, which is a medical system used to measure the severity of kidney damage.
    • You or your legal representative (someone authorized to make decisions for you) must provide written informed consent, which is a formal document stating that you understand and agree to participate in the study. In certain emergency situations, special rules may allow for inclusion.

Who cannot join the trial?

12 criteria

  • Having respiratory acidosis, which is a condition where there is too much acid in the blood caused by breathing problems.
  • Having symptomatic hypocalcaemia, which means having low levels of calcium (a mineral important for bones and muscles) in the blood that causes physical symptoms.
  • Having hypernatremia, which is when there is too much sodium (salt) in the blood.
  • Having severe hypokalemia, which is a condition where there is very low levels of potassium (a mineral that helps muscles and nerves work) in the blood.
  • Being on KRT, which stands for kidney replacement therapy (such as dialysis) to do the work of the kidneys, or if your doctor says you need it immediately.
  • Being considered unsuitable for KRT, meaning your medical condition makes kidney replacement therapy unsafe or not helpful for you.
  • Having a high output stoma or ileostomy, which refers to a surgical opening in the abdomen that releases a large amount of fluid.
  • Having percutaneous biliary drainage, which is a procedure where a tube is placed through the skin to drain bile from the liver or gallbladder.
  • Having end stage kidney failure, which means the kidneys have permanently stopped working properly, or having end stage kidney disease (ESKD) while on dialysis.
  • Having a known case of renal tubular acidosis, which is a condition where the kidneys cannot properly remove acid from the body.
  • Having diabetic ketoacidosis, a serious complication of diabetes where the body produces too much acid called ketones.
  • Having high anion gap acid poisoning, which is a type of poisoning (from substances like aspirin or methanol) that causes a dangerous buildup of acid in the blood.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Sodium bicarbonate is a medication given through an intravenous infusion to help manage the acid levels in the body for patients who are critically ill.

What is already known about the treatment

  • Jonosteril Infusionslösung

    This electrolyte solution is administered through an intravenous infusion into the bloodstream. It is a widely used medical product used to maintain or restore the balance of essential salts in the body, especially during critical illness or dehydration. The mixture works by providing vital minerals like sodium, calcium, magnesium, and potassium that help regulate fluid balance and nerve function at a cellular level. It is pharmacologically classified as an electrolyte replacement therapy.

  • Elektrolyt-Infusionslösung 153

    This medication is an intravenous infusion used to replenish essential minerals in patients. It is a standard medical solution used to treat imbalances in body salts that can occur during serious illness. The solution works by delivering specific ions, such as magnesium, potassium, and sodium, directly into the blood to support the electrical signals and fluid balance within cells. It is classified as an electrolyte replacement solution.

  • Sodium hydrogen carbonate

    This substance is administered via intravenous infusion to treat patients suffering from metabolic acidosis. It is a well-established medical treatment used to increase the alkalinity of the blood when it becomes too acidic. At a molecular level, it acts as a buffer that neutralizes excess acid in the body to restore a healthy chemical balance. This medication is classified as an alkalizing agent.

  • Sterofundin ISO Infusionslösung

    This is an intravenous infusion solution used to manage mineral levels in the body. It is commonly used in clinical settings to treat patients who have lost important salts due to illness or injury. The solution works by providing a balanced mix of electrolytes, including magnesium, potassium, and sodium, which help maintain the proper electrical charge and fluid movement in cells. It is pharmacologically categorized as an electrolyte replacement therapy.

  • Ringer-Infusionslösung B. Braun

    This medication is an intravenous solution used to replace fluids and essential salts in the body. It is a standard clinical tool used to treat dehydration or electrolyte imbalances in various medical conditions. The solution works by supplying sodium, potassium, and calcium directly to the bloodstream to support vital cellular functions and fluid stability. It is classified as an electrolyte replacement solution.

Investigated diseases

  • Metabolic acidosis

    This condition occurs when there is too much acid in the body fluids. It happens when the body produces too much acid or when the kidneys are not able to remove enough acid from the system. The imbalance can lead to a drop in the blood's pH level. As it progresses, the body may attempt to compensate by changing breathing patterns. It is often linked to issues with kidney function or metabolic processes.

  • Critical illness

    This refers to a state where a person's organs are not functioning properly, requiring intensive medical monitoring. The condition often involves rapid changes in vital signs or organ systems. It can progress as different bodily functions become increasingly unstable. The severity depends on which organ systems are failing to maintain normal operations.

  • Acute kidney injury

    This is a sudden episode of kidney failure or damage that happens within a short period. It results in the kidneys being unable to filter waste products from the blood effectively. The condition can develop rapidly over hours or even minutes. If the underlying cause is not addressed, the kidney function may continue to decline. It often presents as a significant increase in waste products in the bloodstream.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523914-10-00Protocol codeUniMs23_0017Estimated enrolment660 patientsSponsorUniversitaet Muenster

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.