Cardiac Arrest Clinical Trial
— BIHCAOfficial title:
Bicarbonate for In-Hospital Cardiac Arrest - A Randomized, Double-Blind, Placebo-Controlled Trial
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.
Status | Recruiting |
Enrollment | 778 |
Est. completion date | February 1, 2026 |
Est. primary completion date | May 28, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Hospital of Southern Jutland - Aabenraa | Aabenraa | |
Denmark | Aalborg University Hospital | Aalborg | |
Denmark | Aarhus University Hospital | Aarhus | |
Denmark | Copenhagen University Hospital - Bispebjerg | Bispebjerg | |
Denmark | Copenhagen University Hospital - Rigshospitalet | Copenhagen | |
Denmark | Hospital of Southwest Jutland - Esbjerg | Esbjerg | |
Denmark | Copenhagen University Hospital - Gentofte | Gentofte | |
Denmark | Gødstrup Hospital | Gødstrup | |
Denmark | Copenhagen University Hospital - Herlev | Herlev | |
Denmark | North Denmark Region Hospital - Hjørring | Hjørring | |
Denmark | Holbæk Hospital | Holbæk | |
Denmark | Horsens Regional Hospital | Horsens | |
Denmark | Hvidovre Hospital | Hvidovre | |
Denmark | Zealand University Hospital - Køge | Køge | |
Denmark | Kolding Hospital | Kolding | |
Denmark | Nykøbing Falster Hospital | Nykøbing Falster | |
Denmark | Odense University Hospital | Odense | |
Denmark | Randers Regional Hospital | Randers | |
Denmark | Zealand University Hospital - Roskilde | Roskilde | |
Denmark | Slagelse Hospital | Slagelse | |
Denmark | Odense University Hospital - Svendborg | Svendborg | |
Denmark | Viborg Regional Hospital | Viborg |
Lead Sponsor | Collaborator |
---|---|
Lars Wiuff Andersen | University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Survival | At 90 days, 180 days, and 1 year | ||
Other | Favorable Neurological Outcome | 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. | At 90 days, 180 days, and 1 year | |
Other | Health-related Quality of Life (EQ-5D-5L) | 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). | At 30 days, 90 days, 180 days, and 1 year | |
Other | Cerebral performance category | 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. | At 30 days, 90 days, 180 days, and 1 year | |
Other | Sequential Organ Failure Assessment (SOFA) Score | 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. | At 2, 24, 48 and 72 hours | |
Other | Hospital Disposition | Hospital disposition (e.g. home, rehabilitation, nursing home, hospice) will be defined at the time of discharge from the initial acute care hospital. | At hospital discharge, up to 1 year | |
Other | pH | Unit: None | Immediately after return of spontaneous circulation, often within 1 hour | |
Other | Standard bicarbonate | Unit: mmol/L | Immediately after return of spontaneous circulation, often within 1 hour | |
Other | pCO2 | Partial pressure of CO2 in arterial blood. Unit: kPa | Immediately after return of spontaneous circulation, often within 1 hour | |
Other | Potassium | Unit: mmol/L | Immediately after return of spontaneous circulation, often within 1 hour | |
Other | Calcium | Unit: mmol/L | Immediately after return of spontaneous circulation, often within 1 hour | |
Other | Sodium | Unit: mmol/L | Immediately after return of spontaneous circulation, often within 1 hour | |
Other | Lactate | Unit: mmol/L | Immediately after return of spontaneous circulation, often within 1 hour | |
Primary | Number of Participants With Return of Spontaneous Circulation | Return of spontaneous circulation is defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes | During the cardiac arrest, an average of 20 minutes | |
Secondary | Number of Participants That Survived 30 Days | At 30 days | ||
Secondary | Number of Participants With a Favorable Neurological Outcome 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. | At 30 days |
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