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

Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• In-hospital cardiac arrest

• Age ≥ 18 years

• Received at least one dose of adrenaline during cardiopulmonary resuscitation (CPR)

Locations
Other Locations
Denmark
Hospital of Southern Jutland - Aabenraa
RECRUITING
Aabenraa
Aalborg University Hospital
RECRUITING
Aalborg
Aarhus University Hospital
RECRUITING
Aarhus
Copenhagen University Hospital - Bispebjerg
RECRUITING
Bispebjerg
Copenhagen University Hospital - Rigshospitalet
RECRUITING
Copenhagen
Hospital of Southwest Jutland - Esbjerg
RECRUITING
Esbjerg
Copenhagen University Hospital - Gentofte
RECRUITING
Gentofte Municipality
Gødstrup Hospital
RECRUITING
Gødstrup
Copenhagen University Hospital - Herlev
RECRUITING
Herlev
North Denmark Region Hospital - Hjørring
RECRUITING
Hjørring
Holbæk Hospital
RECRUITING
Holbæk
Horsens Regional Hospital
RECRUITING
Horsens
Hvidovre Hospital
RECRUITING
Hvidovre
Zealand University Hospital - Køge
RECRUITING
Køge
Kolding Hospital
RECRUITING
Kolding
Nykøbing Falster Hospital
NOT_YET_RECRUITING
Nykøbing Falster
Odense University Hospital
RECRUITING
Odense
Randers Regional Hospital
NOT_YET_RECRUITING
Randers
Zealand University Hospital - Roskilde
RECRUITING
Roskilde
Slagelse Hospital
RECRUITING
Slagelse
Odense University Hospital - Svendborg
RECRUITING
Svendborg
Viborg Regional Hospital
RECRUITING
Viborg
Contact Information
Primary
Lars W Andersen
lwandersen@clin.au.dk
+4551781511
Backup
Asger Granfeldt
granfeldt@clin.au.dk
Time Frame
Start Date: 2023-02-06
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 778
Treatments
Experimental: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Aarhus
Leads: Lars Wiuff Andersen

This content was sourced from clinicaltrials.gov

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