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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05564130
Other study ID # 00004
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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