Bicarbonate for In-Hospital Cardiac Arrest
- Registration Number
- NCT05564130
- Lead Sponsor
- Lars Wiuff Andersen
- 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 o...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 778
- In-hospital cardiac arrest
- Age ≥ 18 years
- Received at least one dose of adrenaline during cardiopulmonary resuscitation (CPR)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sodium bicarbonate 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 Sodium chloride 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Return of Spontaneous Circulation 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 Outcome Measures
Name Time Method Number of Participants With a Favorable Neurological Outcome at 30 Days 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.
Number of Participants That Survived 30 Days At 30 days
Trial Locations
- Locations (22)
Nykøbing Falster Hospital
🇩🇰Nykøbing Falster, Denmark
Hospital of Southern Jutland - Aabenraa
🇩🇰Aabenraa, Denmark
Copenhagen University Hospital - Herlev
🇩🇰Herlev, Denmark
Odense University Hospital - Svendborg
🇩🇰Svendborg, Denmark
Viborg Regional Hospital
🇩🇰Viborg, Denmark
Hospital of Southwest Jutland - Esbjerg
🇩🇰Esbjerg, Denmark
Horsens Regional Hospital
🇩🇰Horsens, Denmark
Hvidovre Hospital
🇩🇰Hvidovre, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
Randers Regional Hospital
🇩🇰Randers, Denmark
Zealand University Hospital - Roskilde
🇩🇰Roskilde, Denmark
Slagelse Hospital
🇩🇰Slagelse, Denmark
Aalborg University Hospital
🇩🇰Aalborg, Denmark
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Copenhagen University Hospital - Bispebjerg
🇩🇰Bispebjerg, Denmark
Copenhagen University Hospital - Rigshospitalet
🇩🇰Copenhagen, Denmark
Copenhagen University Hospital - Gentofte
🇩🇰Gentofte, Denmark
Gødstrup Hospital
🇩🇰Gødstrup, Denmark
Holbæk Hospital
🇩🇰Holbæk, Denmark
North Denmark Region Hospital - Hjørring
🇩🇰Hjørring, Denmark
Kolding Hospital
🇩🇰Kolding, Denmark
Zealand University Hospital - Køge
🇩🇰Køge, Denmark