Bicarbonate for In-Hospital Cardiac Arrest (BIHCA)

Lars Wiuff Andersen

Status and phase: Enrolling; Phase 4

Conditions: Cardiac Arrest

Treatments: Drug: Sodium chloride; Drug: Sodium bicarbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT05564130

00004

Details and patient eligibility

About

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.

Enrollment: 778 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

778 participants in 2 patient groups, including a placebo group

Sodium bicarbonate

Experimental group

Description:

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.

Treatment:

Drug: Sodium bicarbonate

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Sodium chloride