Cardiac Arrest
Conditions
Brief summary
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.
Interventions
Sodium bicarbonate 1 mmol/ml
Sodium chloride 9 mg/mL
Sponsors
Study design
Eligibility
Inclusion criteria
1. In-hospital cardiac arrest 2. Age ≥ 18 years 3. Received at least one dose of adrenaline during cardiopulmonary resuscitation (CPR)
Exclusion criteria
1. Clearly documented "do-not-resuscitate" order prior to the cardiac arrest 2. Prior enrollment in the trial 3. Invasive mechanical circulatory support at the time of the cardiac arrest 4. Known or suspected pregnancy at the time of the cardiac arrest 5. Known objection by the patient to participate in the trial 6. Clinical indication for bicarbonate administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Return of Spontaneous Circulation | During the cardiac arrest, an average of 20 minutes | Return of spontaneous circulation is defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Survived 30 Days | At 30 days | — |
| Number of Participants With a Favorable Neurological Outcome at 30 Days | 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. |
Countries
Denmark
Contacts
Aarhus University Hospital