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Bicarbonate for In-Hospital Cardiac Arrest

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05564130
Acronym
BIHCA
Enrollment
778
Registered
2022-10-03
Start date
2023-02-06
Completion date
2027-02-11
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

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

DRUGSodium bicarbonate

Sodium bicarbonate 1 mmol/ml

DRUGSodium chloride

Sodium chloride 9 mg/mL

Sponsors

Lars Wiuff Andersen
Lead SponsorOTHER
University of Aarhus
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Number of Participants With Return of Spontaneous CirculationDuring the cardiac arrest, an average of 20 minutesReturn of spontaneous circulation is defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes

Secondary

MeasureTime frameDescription
Number of Participants That Survived 30 DaysAt 30 days
Number of Participants With a Favorable Neurological Outcome at 30 DaysAt 30 daysA 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

PRINCIPAL_INVESTIGATORLars W Andersen

Aarhus University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026