Bicarbonate for In-Hospital Cardiac Arrest – A Randomized, Double-Blind, Placebo-Controlled Trial

The primary objective of this study is to evaluate whether **sodium bicarbonate**, compared to placebo, enhances the return of spontaneous circulation when administered during an **in-hospital cardiac arrest**. This is clinically significant as achieving spontaneous circulation is a critical determinant of survival and recovery in cardiac arrest patients.

Secondary objectives include determining whether sodium bicarbonate, as opposed to placebo, improves survival at 30 days and survival at 30 days with a favorable neurological outcome. These outcomes are essential for assessing the long-term benefits and neurological recovery of patients post-cardiac arrest.

The clinical trial focuses on participants experiencing **in-hospital cardiac arrest**. The study population includes both male and female subjects aged 18 years and older. Participants are required to have received at least one dose of adrenaline during cardiopulmonary resuscitation. The trial involves a vulnerable population, as it includes individuals who have experienced a critical medical event. The sponsor has not provided information regarding the total number of participants. The selection criteria ensure that the study population is representative of those who are most likely to benefit from the intervention being tested. Lifestyle considerations such as diet, physical activity, and habits are not specified in the available data.

The clinical trial is designed to evaluate the efficacy of **sodium bicarbonate** compared to a placebo in increasing the return of spontaneous circulation during in-hospital cardiac arrest. This study is a randomized, double-blind, placebo-controlled trial, ensuring that neither the participants nor the researchers know which treatment is being administered, thus minimizing bias. The trial is set to run from November 1, 2022, to October 31, 2026, with the primary endpoint being the return of spontaneous circulation. Secondary endpoints include survival at 30 days and survival at 30 days with a favorable neurological outcome, as measured by the modified Rankin Scale score of 0 to 3.

Participants will be screened based on specific inclusion criteria: they must have experienced an in-hospital cardiac arrest, be aged 18 years or older, and have received at least one dose of adrenaline during cardiopulmonary resuscitation. There are no specified exclusion criteria. The trial involves the administration of the investigational product, **sodium bicarbonate**, or a placebo, both delivered via intravenous injection. The maximum daily dose for both the test and placebo is 100 millimoles or milliliters, respectively, with a treatment period limited to one day.

The sequence of study visits includes an initial screening visit to confirm eligibility, followed by the administration of the investigational product during the cardiac arrest event. Follow-up visits will be conducted to assess the primary and secondary endpoints, with the final visit marking the end of the study. The expected length of participant involvement is limited to the duration of the cardiac arrest event and subsequent follow-up assessments. Participants may be terminated early from the study if they do not meet the inclusion criteria or if any unforeseen medical conditions arise that contraindicate continued participation.

The clinical trial involves the administration of **sodium hydrogen carbonate** as the experimental medication. This compound is provided under the product name "Natriumbikarbonat 'SAD', koncentrat til infusionsvæske, opløsning" and is formulated as a **solution for infusion**. The pharmaceutical form is a concentrate for infusion solution, and it is administered via **intravenous injection**. The maximum daily dose is 100 millimoles, with a total maximum dose of 100 millimoles over a treatment period of one day. The active substance, sodium hydrogen carbonate, is of chemical origin and is classified under the ATC code B05XA02. The product is not a paediatric formulation and is not designated as an orphan drug.

The comparator treatment in this study is **sodium chloride**, provided as a placebo. It is marketed under the name "Natriumklorid isotonisk 'SAD', injektionsvæske, opløsning" and is available as a **solution for injection**. This placebo is also administered via **intravenous injection**. The dosing schedule mirrors that of the experimental treatment, with a maximum daily dose of 100 millilitres and a total maximum dose of 100 millilitres over a one-day treatment period. Sodium chloride, like the experimental medication, is of chemical origin and is categorized under the ATC code V07AB, which includes solvents and diluting agents. This product is also not a paediatric formulation and does not have orphan drug status.

Efficacy in the clinical trial titled "Bicarbonate for In-Hospital Cardiac Arrest – A Randomized, Double-Blind, Placebo-Controlled Trial" will be assessed using specific primary and secondary endpoints. The primary endpoint is the **return of spontaneous circulation**. Secondary endpoints include survival at 30 days and survival at 30 days with a favorable neurological outcome, as measured by the modified Rankin Scale score ranging from 0 to 3. These endpoints will be evaluated to determine the effectiveness of sodium bicarbonate compared to a placebo in increasing the return of spontaneous circulation during in-hospital cardiac arrest.