Bicarbonate for In-Hospital Cardiac Arrest

Cardiac Arrest Clinical Trial

— BIHCA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05564130
• Other study ID #: 00004
• Status: Recruiting
• Phase: Phase 4
• Start date: February 6, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: October 2023
• Source: Aarhus University Hospital
• Contact: Lars W Andersen
• Phone: +4551781511
• Email: lwandersen[@]clin.au.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Drug:
• Sodium bicarbonate
Sodium bicarbonate 1 mmol/ml
• Sodium chloride
Sodium chloride 9 mg/mL

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Lars Wiuff Andersen	University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

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