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

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What is this study about?

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.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Technische Universitaet Dresden	Dresden	Germany
Rostock University Medical Center	Rostock	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Universitaetsmedizin Goettingen	Goettingen	Germany

Other Sites

Site Name	City	Country
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Klinikum Dortmund gGmbH	Dortmund	Germany
Universitaetsklinikum Aachen AöR	Aachen	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Evangelisches Klinikum Bethel gGmbH	Bielefeld	Germany
Universitaetsklinikum Leipzig AöR	Leipzig	Germany
Khhgmypq Bwooesig Ghhd	Bayreuth	Germany
Kcafuolh ddk Ucpucuhbopul Mpjlodyl Awi	Munich	Germany
Uzjpmpsthx Mocrdeh Cdwbxe Hvutxlumcnnrbjbrd	Hamburg	Germany
Uzrsukrnnfezmyhvlobri Exukg Azg	Essen	Germany
Usperesknomragqajsxrq Akpkkvnk	Augsburg	Germany
Ugcvkpezgxdoznhhfcxre Mmasiebf Acn	Munster	Germany
Uucxjdjuysrdflmsnlwcu Wwhteedas Amf	Wuerzburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	02.03.2026

Trial locations

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.

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 ID:

2025-523914-10-00

Protocol code:

UniMs23_0017

Trial Phase:

Therapeutic confirmatory (Phase III)

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