Bicarbonate for In-Hospital Cardiac Arrest

Study Overview
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Brief Summary
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This is an investigator-initiated, multicenter, randomized, placebo-controlled, parallel group, double-blind, superiority trial of sodium bicarbonate during adult in-hospital cardiac arrest. There will be 22 enrolling sites in Denmark. 778 adult patients with in-hospital cardiac arrest receiving at least one dose of adrenaline will be enrolled. The primary outcome is return of spontaneous circulation and key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.

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

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Drug: Sodium bicarbonate
* Drug: Sodium chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In-hospital cardiac arrest Age ≥ 18 years Received at least one dose of adrenaline during cardiopulmonary resuscitation (CPR) Exclusion Criteria: Clearly documented do-not-resuscitate order prior to the cardiac arrest Prior enrollment in the trial Invasive mechanical circulatory support at the time of the cardiac arrest Known or suspected pregnancy at the time of the cardiac arrest Known objection by the patient to participate in the trial Clinical indication for bicarbonate administration

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium bicarbonate<br>50 ml of 1 mmol/ml sodium bicarbonate given as soon as possible after the first dose of adrenaline. If the patient remains in cardiac arrest, one additional dose of 50 ml of 1 mmol/ml sodium bicarbonate will be administered after the second dose of adrenaline dose for a maximum of two doses. | Drug: Sodium bicarbonate<br>* Sodium bicarbonate 1 mmol/ml<br>|
| Placebo Comparator: Placebo<br>50 mL of 9 mg/mL NaCl (normal saline) given as soon as possible after the first dose of adrenaline. If the patient remains in cardiac arrest, one additional dose of 50 mL of 9 mg/mL NaCl will be administered after the second dose of adrenaline dose for a maximum of two doses. | Drug: Sodium chloride<br>* Sodium chloride 9 mg/mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Return of Spontaneous Circulation | Return of spontaneous circulation is defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes | During the cardiac arrest, an average of 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Survived 30 Days |  | At 30 days | 
| Number of Participants With a Favorable Neurological Outcome at 30 Days | A favorable neurological outcome will be defined as a modified Rankin Scale score of 0, 1, 2 or 3. The modified Rankin Scale is a 7-point scale assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes. | At 30 days |