Bicarbonate for In-Hospital Cardiac Arrest

NCT ID: NCT05564130

Last Updated: 2026-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

778 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-06

Study Completion Date

2027-02-11

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.

Detailed Description

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Conditions

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Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sodium bicarbonate

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.

Group Type EXPERIMENTAL

Sodium bicarbonate

Intervention Type DRUG

Sodium bicarbonate 1 mmol/ml

Placebo

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.

Group Type PLACEBO_COMPARATOR

Sodium chloride

Intervention Type DRUG

Sodium chloride 9 mg/mL

Interventions

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Sodium bicarbonate

Sodium bicarbonate 1 mmol/ml

Intervention Type DRUG

Sodium chloride

Sodium chloride 9 mg/mL

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role collaborator

Lars Wiuff Andersen

OTHER

Sponsor Role lead

Responsible Party

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Lars Wiuff Andersen

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lars W Andersen

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Hospital of Southern Jutland - Aabenraa

Aabenraa, , Denmark

Site Status

Aalborg University Hospital

Aalborg, , Denmark

Site Status

Aarhus University Hospital

Aarhus, , Denmark

Site Status

Copenhagen University Hospital - Bispebjerg

Bispebjerg, , Denmark

Site Status

Copenhagen University Hospital - Rigshospitalet

Copenhagen, , Denmark

Site Status

Hospital of Southwest Jutland - Esbjerg

Esbjerg, , Denmark

Site Status

Copenhagen University Hospital - Gentofte

Gentofte Municipality, , Denmark

Site Status

Gødstrup Hospital

Gødstrup, , Denmark

Site Status

Copenhagen University Hospital - Herlev

Herlev, , Denmark

Site Status

North Denmark Region Hospital - Hjørring

Hjørring, , Denmark

Site Status

Holbæk Hospital

Holbæk, , Denmark

Site Status

Horsens Regional Hospital

Horsens, , Denmark

Site Status

Hvidovre Hospital

Hvidovre, , Denmark

Site Status

Kolding Hospital

Kolding, , Denmark

Site Status

Zealand University Hospital - Køge

Køge, , Denmark

Site Status

Nykøbing Falster Hospital

Nykøbing Falster, , Denmark

Site Status

Odense University Hospital

Odense, , Denmark

Site Status

Randers Regional Hospital

Randers, , Denmark

Site Status

Zealand University Hospital - Roskilde

Roskilde, , Denmark

Site Status

Slagelse Hospital

Slagelse, , Denmark

Site Status

Odense University Hospital - Svendborg

Svendborg, , Denmark

Site Status

Viborg Regional Hospital

Viborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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00004

Identifier Type: -

Identifier Source: org_study_id

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