Clinical trial NCT05564130: Bicarbonate for In-Hospital Cardiac Arrest
Official title: Bicarbonate for In-Hospital Cardiac Arrest - A Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cardiac Arrest
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
First posted: 2022-10-03
Enrollment: 778
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Return of Spontaneous Circulation
timeFrame: During the cardiac arrest, an average of 20 minutes
Secondary outcomes:
measure: Number of Participants That Survived 30 Days
timeFrame: At 30 days
measure: Number of Participants With a Favorable Neurological Outcome at 30 Days
timeFrame: At 30 days
Other outcomes:
measure: Survival
timeFrame: At 90 days, 180 days, and 1 year
measure: Favorable Neurological Outcome
timeFrame: At 90 days, 180 days, and 1 year
measure: Health-related Quality of Life (EQ-5D-5L)
timeFrame: At 30 days, 90 days, 180 days, and 1 year
measure: Cerebral performance category
timeFrame: At 30 days, 90 days, 180 days, and 1 year
measure: Sequential Organ Failure Assessment (SOFA) Score
timeFrame: At 2, 24, 48 and 72 hours
measure: Hospital Disposition
timeFrame: At hospital discharge, up to 1 year
measure: pH
timeFrame: Immediately after return of spontaneous circulation, often within 1 hour
measure: Standard bicarbonate
timeFrame: Immediately after return of spontaneous circulation, often within 1 hour
measure: pCO2
timeFrame: Immediately after return of spontaneous circulation, often within 1 hour
measure: Potassium
timeFrame: Immediately after return of spontaneous circulation, often within 1 hour
measure: Calcium
timeFrame: Immediately after return of spontaneous circulation, often within 1 hour
measure: Sodium
timeFrame: Immediately after return of spontaneous circulation, often within 1 hour
measure: Lactate
timeFrame: Immediately after return of spontaneous circulation, often within 1 hour
Locations:
city: Aabenraa
country: Denmark
facility: Hospital of Southern Jutland - Aabenraa
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Bispebjerg
country: Denmark
facility: Copenhagen University Hospital - Bispebjerg
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital - Rigshospitalet
city: Esbjerg
country: Denmark
facility: Hospital of Southwest Jutland - Esbjerg
city: Gentofte
country: Denmark
facility: Copenhagen University Hospital - Gentofte
city: Gødstrup
country: Denmark
facility: Gødstrup Hospital
city: Herlev
country: Denmark
facility: Copenhagen University Hospital - Herlev
city: Hjørring
country: Denmark
facility: North Denmark Region Hospital - Hjørring
city: Holbæk
country: Denmark
facility: Holbæk Hospital
city: Horsens
country: Denmark
facility: Horsens Regional Hospital
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
city: Kolding
country: Denmark
facility: Kolding Hospital
city: Køge
country: Denmark
facility: Zealand University Hospital - Køge
city: Nykøbing Falster
country: Denmark
facility: Nykøbing Falster Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Randers
country: Denmark
facility: Randers Regional Hospital
city: Roskilde
country: Denmark
facility: Zealand University Hospital - Roskilde
city: Slagelse
country: Denmark
facility: Slagelse Hospital
city: Svendborg
country: Denmark
facility: Odense University Hospital - Svendborg
city: Viborg
country: Denmark
facility: Viborg Regional Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Lars W Andersen
role: PRINCIPAL_INVESTIGATOR
References: