BIHCA: Bicarbonate for In-Hospital Cardiac Arrest
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Sodium bicarbonate
Sodium bicarbonate 1 mmol/ml
|
| 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. |
Drug: Sodium chloride
Sodium chloride 9 mg/mL
|
Outcome Measures
Primary Outcome Measures
- 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
- Number of Participants That Survived 30 Days [At 30 days]
- 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.
Other Outcome Measures
- Survival [At 90 days, 180 days, and 1 year]
- Favorable Neurological Outcome [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.
- Health-related Quality of Life (EQ-5D-5L) [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).
- Cerebral performance category [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.
- Sequential Organ Failure Assessment (SOFA) Score [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.
- Hospital Disposition [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.
- pH [Immediately after return of spontaneous circulation, often within 1 hour]
Unit: None
- Standard bicarbonate [Immediately after return of spontaneous circulation, often within 1 hour]
Unit: mmol/L
- pCO2 [Immediately after return of spontaneous circulation, often within 1 hour]
Partial pressure of CO2 in arterial blood. Unit: kPa
- Potassium [Immediately after return of spontaneous circulation, often within 1 hour]
Unit: mmol/L
- Calcium [Immediately after return of spontaneous circulation, often within 1 hour]
Unit: mmol/L
- Sodium [Immediately after return of spontaneous circulation, often within 1 hour]
Unit: mmol/L
- Lactate [Immediately after return of spontaneous circulation, often within 1 hour]
Unit: mmol/L
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Lars Wiuff Andersen
- University of Aarhus
Investigators
- Principal Investigator: Lars W Andersen, Aarhus University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 00004