Table of contents
- Trial overview
- Critical illness, metabolic acidosis, and acute kidney injury
- Labor and delivery study
- Other trials in the source data
- What the trials measure
- Patient-friendly explanation of key terms
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]
