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Active, Not Recruiting

NCT Number: NCT05564130

Bicarbonate for In-Hospital Cardiac Arrest

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital of Southern Jutland - Aabenraa, Aabenraa, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium bicarbonate

Drug

Sodium bicarbonate 1 mmol/ml

Sodium Chloride

Drug

Sodium chloride 9 mg/mL

Primary outcomes

  1. Number of Participants With Return of Spontaneous Circulation

    Time frame: 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 outcomes

  1. Number of Participants That Survived 30 Days

    Time frame: At 30 days

  2. Number of Participants With a Favorable Neurological Outcome at 30 Days

    Time frame: 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.

Other outcomes

  1. Survival

    Time frame: At 90 days, 180 days, and 1 year

  2. Favorable Neurological Outcome

    Time frame: At 90 days, 180 days, and 1 year

    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.

  3. Health-related Quality of Life (EQ-5D-5L)

    Time frame: At 30 days, 90 days, 180 days, and 1 year

    The EQ-5D-5L is a well-established measure of health-related quality of life that is quantified as a utility (i.e. a measure of quality of life between 0 and 1).

  4. Cerebral performance category

    Time frame: At 30 days, 90 days, 180 days, and 1 year

    The cerebral performance category score is a 5-point scale assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes.

  5. Sequential Organ Failure Assessment (SOFA) Score

    Time frame: At 2, 24, 48 and 72 hours

    The SOFA score is a validated and widely used measure of organ failure assessing the respiratory, nervous, cardiovascular, hepatic, coagulation, and renal systems. We will assess both the cardiovascular sub score as well as the overall SOFA score.

  6. Hospital Disposition

    Time frame: At hospital discharge, up to 1 year

    Hospital disposition (e.g. home, rehabilitation, nursing home, hospice) will be defined at the time of discharge from the initial acute care hospital.

  7. pH

    Time frame: Immediately after return of spontaneous circulation, often within 1 hour

    Unit: None

  8. Standard bicarbonate

    Time frame: Immediately after return of spontaneous circulation, often within 1 hour

    Unit: mmol/L

  9. pCO2

    Time frame: Immediately after return of spontaneous circulation, often within 1 hour

    Partial pressure of CO2 in arterial blood. Unit: kPa

  10. Potassium

    Time frame: Immediately after return of spontaneous circulation, often within 1 hour

    Unit: mmol/L

  11. Calcium

    Time frame: Immediately after return of spontaneous circulation, often within 1 hour

    Unit: mmol/L

  12. Sodium

    Time frame: Immediately after return of spontaneous circulation, often within 1 hour

    Unit: mmol/L

  13. Lactate

    Time frame: Immediately after return of spontaneous circulation, often within 1 hour

    Unit: mmol/L

Sponsors and collaborators

Lead sponsor

Lars Wiuff Andersen

Other

Collaborators

  • University of Aarhus

Registry information

Official study title

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

Acronym: BIHCA

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 3, 2022
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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