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Bicarbonate for In-Hospital Cardiac Arrest (BIHCA)

Primary Purpose

Cardiac Arrest

Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Sodium bicarbonate
Sodium chloride
Sponsored by
Lars Wiuff Andersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital of Southern Jutland - AabenraaRecruiting
  • Aalborg University HospitalRecruiting
  • Aarhus University HospitalRecruiting
  • Copenhagen University Hospital - BispebjergRecruiting
  • Copenhagen University Hospital - RigshospitaletRecruiting
  • Hospital of Southwest Jutland - EsbjergRecruiting
  • Copenhagen University Hospital - GentofteRecruiting
  • Gødstrup HospitalRecruiting
  • Copenhagen University Hospital - HerlevRecruiting
  • North Denmark Region Hospital - HjørringRecruiting
  • Holbæk HospitalRecruiting
  • Horsens Regional HospitalRecruiting
  • Hvidovre HospitalRecruiting
  • Kolding HospitalRecruiting
  • Zealand University Hospital - KøgeRecruiting
  • Nykøbing Falster Hospital
  • Odense University HospitalRecruiting
  • Randers Regional Hospital
  • Zealand University Hospital - RoskildeRecruiting
  • Slagelse HospitalRecruiting
  • Odense University Hospital - SvendborgRecruiting
  • Viborg Regional HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sodium bicarbonate

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants That Survived 30 Days
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.

Full Information

First Posted
September 27, 2022
Last Updated
October 9, 2023
Sponsor
Lars Wiuff Andersen
Collaborators
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT05564130
Brief Title
Bicarbonate for In-Hospital Cardiac Arrest
Acronym
BIHCA
Official Title
Bicarbonate for In-Hospital Cardiac Arrest - A Randomized, Double-Blind, Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
May 28, 2025 (Anticipated)
Study Completion Date
February 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lars Wiuff Andersen
Collaborators
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
778 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sodium bicarbonate
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sodium bicarbonate
Intervention Description
Sodium bicarbonate 1 mmol/ml
Intervention Type
Drug
Intervention Name(s)
Sodium chloride
Intervention Description
Sodium chloride 9 mg/mL
Primary Outcome Measure Information:
Title
Number of Participants With Return of Spontaneous Circulation
Description
Return of spontaneous circulation is defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes
Time Frame
During the cardiac arrest, an average of 20 minutes
Secondary Outcome Measure Information:
Title
Number of Participants That Survived 30 Days
Time Frame
At 30 days
Title
Number of Participants With a Favorable Neurological Outcome at 30 Days
Description
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.
Time Frame
At 30 days
Other Pre-specified Outcome Measures:
Title
Survival
Time Frame
At 90 days, 180 days, and 1 year
Title
Favorable Neurological Outcome
Description
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.
Time Frame
At 90 days, 180 days, and 1 year
Title
Health-related Quality of Life (EQ-5D-5L)
Description
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).
Time Frame
At 30 days, 90 days, 180 days, and 1 year
Title
Cerebral performance category
Description
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.
Time Frame
At 30 days, 90 days, 180 days, and 1 year
Title
Sequential Organ Failure Assessment (SOFA) Score
Description
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.
Time Frame
At 2, 24, 48 and 72 hours
Title
Hospital Disposition
Description
Hospital disposition (e.g. home, rehabilitation, nursing home, hospice) will be defined at the time of discharge from the initial acute care hospital.
Time Frame
At hospital discharge, up to 1 year
Title
pH
Description
Unit: None
Time Frame
Immediately after return of spontaneous circulation, often within 1 hour
Title
Standard bicarbonate
Description
Unit: mmol/L
Time Frame
Immediately after return of spontaneous circulation, often within 1 hour
Title
pCO2
Description
Partial pressure of CO2 in arterial blood. Unit: kPa
Time Frame
Immediately after return of spontaneous circulation, often within 1 hour
Title
Potassium
Description
Unit: mmol/L
Time Frame
Immediately after return of spontaneous circulation, often within 1 hour
Title
Calcium
Description
Unit: mmol/L
Time Frame
Immediately after return of spontaneous circulation, often within 1 hour
Title
Sodium
Description
Unit: mmol/L
Time Frame
Immediately after return of spontaneous circulation, often within 1 hour
Title
Lactate
Description
Unit: mmol/L
Time Frame
Immediately after return of spontaneous circulation, often within 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lars W Andersen
Phone
+4551781511
Email
lwandersen@clin.au.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Asger Granfeldt
Email
granfeldt@clin.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars W Andersen
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of Southern Jutland - Aabenraa
City
Aabenraa
ZIP/Postal Code
6200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Eskol
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Signe Riddersholm
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asger Granfeldt
Facility Name
Copenhagen University Hospital - Bispebjerg
City
Bispebjerg
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theis Itenov
Facility Name
Copenhagen University Hospital - Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Isbye
Facility Name
Hospital of Southwest Jutland - Esbjerg
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Qvist
Facility Name
Copenhagen University Hospital - Gentofte
City
Gentofte
ZIP/Postal Code
2900
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fredrik Folke
Facility Name
Gødstrup Hospital
City
Gødstrup
ZIP/Postal Code
7400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rasmus Nielsen
Facility Name
Copenhagen University Hospital - Herlev
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kasper Iversen
Facility Name
North Denmark Region Hospital - Hjørring
City
Hjørring
ZIP/Postal Code
9800
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrei Ciubotariu
Facility Name
Holbæk Hospital
City
Holbæk
ZIP/Postal Code
4300
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mette Krag
Facility Name
Horsens Regional Hospital
City
Horsens
ZIP/Postal Code
8700
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrick Espelund
Facility Name
Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klaus Kristiansen
Facility Name
Kolding Hospital
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Brøchner
Facility Name
Zealand University Hospital - Køge
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rikke Malene Jepsen
Facility Name
Nykøbing Falster Hospital
City
Nykøbing Falster
ZIP/Postal Code
4800
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ninna Holm
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Søren Darling
Facility Name
Randers Regional Hospital
City
Randers
ZIP/Postal Code
8930
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Løfgren
Facility Name
Zealand University Hospital - Roskilde
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camilla Asferg
Facility Name
Slagelse Hospital
City
Slagelse
ZIP/Postal Code
4200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morten Plambech
Facility Name
Odense University Hospital - Svendborg
City
Svendborg
ZIP/Postal Code
5700
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Martin Hansen
Facility Name
Viborg Regional Hospital
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoffer Sølling

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Six months after the publication of the last results, all de-identified individual patient data will be made available for data sharing. Procedures, including re-coding of key variables, will be put in place to allow for complete de-identification of the data. Data will be completely anonymized according to Danish law. All relevant trial-related documents, including the protocol, data dictionary, and the main statistical code, will be shared along with the data. There will be no predetermined end date for the data sharing.
IPD Sharing Access Criteria
Data will be available for any research purpose to all interested parties who have approval from an independent review committee and who have a methodological sound proposal as determined by the steering committee of the current trial. Only the methodological qualities and not the purpose or objective of the proposal will be considered. Interested parties will be able to request the data by contacting the principal investigator. Authorship of publications emerging from the shared data will follow standard authorship guidelines from the International Committee of Medical Journal Editors and might or might not include authors from the steering committee depending on the nature of their involvement.

Learn more about this trial

Bicarbonate for In-Hospital Cardiac Arrest

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