In short
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.
Key points
- Clinical trials investigating Sodium Hydrogen Carbonate are being done in different patient groups, especially critically ill patients, pregnant women, and people with acute kidney injury. The main Phase 3 trial in the data looks at major adverse kidney events at 90 days. Another Phase 3 study looks at whether Sodium Hydrogen Carbonate can help support spontaneous delivery during labor. The studies use different comparison groups, depending on the clinical setting. Overall, the research is focused on whether Sodium Hydrogen Carbonate improves important patient outcomes in real hospital care.
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. It is a Phase 3 interventional study with 660 participants and a primary outcome called major adverse kidney events at 90 days.
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. The data also includes several other trials that use bicarbonate-related products or similar names, but they study different conditions and treatments.
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. It is an authorised Phase 3 interventional study with 660 participants.
This study includes patients with metabolic acidosis, critical illness, and acute kidney injury. The intervention list includes Sodium Hydrogen Carbonate given by intravenous perfusion, compared with other infusion solutions.
The main goal is to investigate the effect of Sodium Hydrogen Carbonate on major adverse kidney events (MAKE90) at day 90. MAKE90 is a combined outcome that includes death, need for kidney replacement therapy, or persistent kidney dysfunction by day 90.
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. It is a Phase 3 interventional study with 3,000 participants.
This study evaluates oral bicarbonate and intravenous butylscopolamine bromide to help facilitate spontaneous delivery. The primary outcome is whether delivery is spontaneous or operative, with operative delivery defined as cesarean delivery, vacuum, or forceps.
This trial is important because it studies a common labor outcome in a large group of pregnant participants. The design also includes a placebo tablet, which helps compare the study treatment with no active treatment.
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. Its main outcome is the Quality Of recovery score (QOR 15) at day 1, which measures early recovery after surgery.
Another Phase 3 trial studies bicarbonate for in-hospital cardiac arrest and measures return of spontaneous circulation. This is a very different emergency setting from the kidney and labor studies.
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. Although it is related to bicarbonate in the study data, it is a different product and a different condition.
What the trials measure
Trial endpoints are the main results researchers want to measure.
- MAKE90 in the kidney study means a combined kidney outcome measured by day 90. It includes death, dialysis or other kidney replacement therapy, or lasting kidney damage.
- Spontaneous versus operative delivery in the labor study checks whether birth happens without tools or surgery, or whether cesarean, vacuum, or forceps are needed.
- QOR 15 in the surgery study measures how well patients recover on day 1 after the operation.
- Return of spontaneous circulation in the cardiac arrest study checks whether the heart starts beating again on its own.
- Complete spontaneous bowel movements in the constipation study are used to track treatment safety, tolerability, and compliance in patient diaries.
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.
Interventional means the researchers assign a treatment and watch what happens.
Randomized means people are placed into study groups by chance, which helps make the comparison fair. Placebo means a look-alike treatment without active medicine.
Intravenous means given into a vein, and oral means taken by mouth.