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Sodium Hydrogen Carbonate

Clinical trials investigating Sodium Hydrogen Carbonate are studying its use in different patient groups, including critically ill patients, pregnant women, and people in labor or with kidney problems. These studies mainly look at safety, effectiveness, and patient outcomes in specific clinical settings.

Table of contents

Trial overview

The source data includes one trial that directly studies Sodium Hydrogen Carbonate in critically ill patients with metabolic acidosis and acute kidney injury.[1] It is a Phase 3 interventional study with 660 participants and a primary outcome called major adverse kidney events at 90 days.[1]

Another Phase 3 trial studies oral bicarbonate in pregnant women with induction of labor and looks at whether delivery happens spontaneously or needs operative help.[2] The data also includes several other trials that use bicarbonate-related products or similar names, but they study different conditions and treatments.[3][4][5]

Critical illness, metabolic acidosis, and acute kidney injury

The trial with NCT 2025-523914-10-00 is titled Evaluating the clinical effectiveness of sodium bicarbonate for critically ill patients with metabolic acidosis and acute kidney injury.[1] It is an authorised Phase 3 interventional study with 660 participants.[1]

This study includes patients with metabolic acidosis, critical illness, and acute kidney injury.[1] The intervention list includes Sodium Hydrogen Carbonate given by intravenous perfusion, compared with other infusion solutions.[1]

The main goal is to investigate the effect of Sodium Hydrogen Carbonate on major adverse kidney events (MAKE90) at day 90.[1] MAKE90 is a combined outcome that includes death, need for kidney replacement therapy, or persistent kidney dysfunction by day 90.[1]

Labor and delivery study

The trial with NCT05719467 is a double-blind, randomized, placebo-controlled, four-arm study in pregnant female participants with induction of labor.[2] It is a Phase 3 interventional study with 3,000 participants.[2]

This study evaluates oral bicarbonate and intravenous butylscopolamine bromide to help facilitate spontaneous delivery.[2] The primary outcome is whether delivery is spontaneous or operative, with operative delivery defined as cesarean delivery, vacuum, or forceps.[2]

This trial is important because it studies a common labor outcome in a large group of pregnant participants.[2] The design also includes a placebo tablet, which helps compare the study treatment with no active treatment.[2]

Other trials in the source data

The source data also lists a Phase 3 trial in hand and foot surgery that studies bicarbonate added to local anesthetic protocols under WALANT.[3] Its main outcome is the Quality Of recovery score (QOR 15) at day 1, which measures early recovery after surgery.[3]

Another Phase 3 trial studies bicarbonate for in-hospital cardiac arrest and measures return of spontaneous circulation.[4] This is a very different emergency setting from the kidney and labor studies.[4]

There is also a Phase 3 study in chronic constipation that uses Lecicarbon® and measures tolerability, safety, compliance, and complete spontaneous bowel movements recorded in patient diaries.[5] Although it is related to bicarbonate in the study data, it is a different product and a different condition.[5]

What the trials measure

Trial endpoints are the main results researchers want to measure.[1][2][3][4][5]

  • MAKE90 in the kidney study means a combined kidney outcome measured by day 90.[1] It includes death, dialysis or other kidney replacement therapy, or lasting kidney damage.[1]

  • Spontaneous versus operative delivery in the labor study checks whether birth happens without tools or surgery, or whether cesarean, vacuum, or forceps are needed.[2]

  • QOR 15 in the surgery study measures how well patients recover on day 1 after the operation.[3]

  • Return of spontaneous circulation in the cardiac arrest study checks whether the heart starts beating again on its own.[4]

  • Complete spontaneous bowel movements in the constipation study are used to track treatment safety, tolerability, and compliance in patient diaries.[5]

Patient-friendly explanation of key terms

Phase 3 means the treatment is being tested in a larger group of people, often to compare it with standard care or placebo.[1][2][3][4][5]

Interventional means the researchers assign a treatment and watch what happens.[1][2][3][4][5]

Randomized means people are placed into study groups by chance, which helps make the comparison fair.[2] Placebo means a look-alike treatment without active medicine.[2]

Intravenous means given into a vein, and oral means taken by mouth.[1][2]

Trial IDPhaseCondition studiedStatusEnrollment
2025-523914-10-00Phase 3Metabolic acidosis, critical illness, acute kidney injuryAuthorised660
NCT05719467Phase 3ChildbirthAuthorised3000
2024-519650-36-00Phase 3Hand Surgery, Foot surgeryAuthorised150
2022-501304-10-00Phase 3In-hospital cardiac arrestAuthorised778

FAQ

  • What kinds of clinical trials are studying Sodium Hydrogen Carbonate? The trials are testing Sodium Hydrogen Carbonate in different medical settings, including critical illness, labor, and acute kidney injury. They are mainly looking at whether it helps improve patient outcomes and whether it is safe to use in these situations.
  • Who can take part in these studies? The target groups vary by trial. Some studies include critically ill patients with metabolic acidosis and acute kidney injury, while others include pregnant women with induction of labor.
  • What phase are the Sodium Hydrogen Carbonate trials in? The trial data shows Phase 3 studies. This means the treatment is being tested in larger groups of people to compare outcomes and gather more evidence.
  • What outcomes are being measured? One study measures major adverse kidney events within 90 days. Another looks at whether delivery happens spontaneously or needs to be operative, such as cesarean delivery, vacuum, or forceps.
  • Are these trials testing Sodium Hydrogen Carbonate alone? In the trial data provided, Sodium Hydrogen Carbonate is studied as part of a comparison with other treatment options or placebo in specific settings. The exact setup depends on the trial.

Ongoing Clinical Trials on Sodium Hydrogen Carbonate

  • Study on XyloCore and Drug Combination for Patients with End-Stage Kidney Disease Undergoing Peritoneal Dialysis

    Recruiting

    1 1 1 1
    Investigated drugs:
    Denmark Germany Italy Spain Sweden

  • Study on Preventing Opioid-Induced Constipation in Advanced Cancer Patients Using Magnesium Hydroxide and Macrogol 3350 Combination

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on Reduction of Toxicant Levels in Blood through Combined Digestive Decontamination with Activated Charcoal and Intestinal Purge for Intubated Patients with Major Poisoning in Intensive Care

    Not yet recruiting

    1 1 1
    Investigated drugs:
    France

  • Efficacy and Safety of Mannitol Compared to Plenvu for Bowel Preparation in Patients Undergoing Elective Colonoscopy

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Italy Poland Spain Sweden

  • Study on Sodium Bicarbonate and Sodium Chloride for Patients with In-Hospital Cardiac Arrest

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on Reducing Proton Pump Inhibitor Use in Patients with Heartburn, Reflux, or Dyspepsia: Comparing On-Demand Use, Alginate Therapy, and Gradual Dose Reduction

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

  • Study on the Effectiveness of Oral Sodium Bicarbonate and Intravenous Hyoscine Butylbromide for Facilitating Natural Childbirth in Pregnant Women Induced for Labor

    Not recruiting

    1 1 1
    Investigated drugs:
    Norway

Glossary

  • Clinical trial: A research study in people that tests whether a treatment is safe, works well, or both.
  • Phase 3: A later stage of research with larger numbers of participants. It helps compare a treatment with standard care or placebo.
  • Interventional study: A study where researchers assign a treatment or control to see what happens.
  • Metabolic acidosis: A condition where the blood has too much acid. It can happen in severe illness and kidney problems.
  • Acute kidney injury: A sudden problem where the kidneys do not work as well as they should.
  • Major adverse kidney events (MAKE90): A combined outcome used in kidney studies. It includes death, need for kidney replacement therapy, or lasting kidney damage by day 90.
  • Kidney replacement therapy (KRT): Treatment that helps the kidneys do their job, such as dialysis.
  • Randomization: A process that assigns participants by chance to different study groups.
  • Placebo: A treatment that looks like the study medicine but has no active ingredient.
  • Spontaneous delivery: Birth that happens without operative help such as cesarean delivery, vacuum, or forceps.

References

  1. https://clinicaltrials.gov/study/2025-523914-10-00
  2. https://clinicaltrials.eu/trial/study-on-the-effectiveness-of-oral-sodium-bicarbonate-and-intravenous-hyoscine-butylbromide-for-facilitating-natural-childbirth-in-pregnant-women-induced-for-labor/
  3. https://clinicaltrials.gov/study/2024-519650-36-00
  4. https://clinicaltrials.gov/study/2022-501304-10-00
  5. https://clinicaltrials.gov/study/2025-522464-32-00