Out-of-hospital Cardiac Arrest (OHCA)Phase 2POTACREHNCT04316611
Potassium Chloride in Out-of-hospital Cardiac Arrest Due to Refractory Ventricular Fibrillation
A Phase 2 study testing Potassium chloride in people with Out-of-hospital Cardiac Arrest (OHCA), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to evaluate, in patients presenting with out-of-hospital cardiac arrest (OHCA) by ventricular fibrillation, refractory to 3 external electric shocks, the efficacy of a direct intravenous injection of 20 mmol KCl on their survival at hospital arrival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-of-hospital Cardiac Arrest (OHCA)
- What is being tested?
- Potassium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2023to Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (age 18 or over).
- Patient suffering from an outpatient cardiac arrest of presumed cardiac origin and presenting refractory ventricular fibrillation despite 3 external electric shocks.
- Patient with a health insurance plan.
Who cannot join
- Proven pregnancy.
- Major incompetent (patient under guardianship or curatorship).
- Patient who does not yet have a functional venous pathway after the 3 external electric shocks have been performed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of Potassium Chloride in the Management of Out-of-hospital Cardiac Arrest by Refractory Ventricular Fibrillation
The purpose of this study is to evaluate, in patients presenting with out-of-hospital cardiac arrest (OHCA) by ventricular fibrillation, refractory to 3 external electric shocks, the efficacy of a direct intravenous injection of 20 mmol KCl on their survival at hospital arrival.
Read the detailed description
Out-of-hospital cardiac arrest (OHCA) has a poor prognosis, with an overall survival rate of about 5% at discharge. Shockable rhythm cardiac arrests (ventricular fibrillation (VF) and pulseless ventricular tachycardia) have a better prognosis.
In case of shockable rhythm, treatment is based on defibrillation, thereafter failure of 3 external electric shocks, on direct intravenous administration of 300 mg amiodarone, followed in case of ineffectiveness by an additional direct intravenous administration of 150 mg amiodarone. Lidocaine, which has long been used in this indication, is currently only recommended when amiodarone is unavailable or inefficient. Nevertheless, these 2 drugs, while they may be effective in converting refractory ventricular fibrillation to normal rhythm, have marked cardiodepressant effects (bradycardia, and/or negative inotropic effect) that persist after direct intravenous administration. This explains, at least partially, why a recent study did not show a significant difference in hospital discharge survival between amiodarone, lidocaine and placebo in patients presenting with OHCA by refractory ventricular fibrillation.
During surgical procedures under extracorporeal circulation, a cardioplegia solution is administered to interrupt cardiac activity and facilitate the surgical procedure. From a patho-physiological level, the mode of action of these solutions is based on a high concentration of potassium, which reduces the membrane resting potential of the myocytes. By extension, direct intravenous administration of 20 mmol potassium chloride (KCl) has been shown to convert ventricular fibrillation, resulting in a return to an hemodynamically efficient organized heart rate within a few minutes. The kalemia were at the upper limit of normal (5.5 mmol/l) 10 min after this injection, and normal at 20 min. A recent clinical case of a patient under extracorporeal circulation resuscitation, presenting with a refractory ventricular fibrillation, demonstrated the efficacy of direct intravenous injection of 3 g potassium chloride, resulting in a return to a sinus rhythm within a few minutes.
The immediate advantage of potassium chloride, compared to amiodarone (and also lidocaine), is the absence of cardiodepressant effect (bradycardia and/or hypotension) persisting after a while from the injection time. The mode of action of direct intravenous injection of potassium chloride to reduce ventricular fibrillation is indeed linked to the peak of hyperkalemia, whereas since the kalaemia are afterwards rapidly normalized in a few minutes, there is no persistent deleterious effect following this injection of potassium chloride. In addition, in the case of cardiac arrest, since the patient is already under continuous external cardiac chest compressions, no supplementary deleterious consequences related to this transient hyperkalemia are expected.
Direct intravenous injection of potassium chloride into a patient in out-of-hospital cardiac arrest with refractory ventricular fibrillation with 3 external electric shocks, instead of amiodarone, should interrupt this ventricular fibrillation and then allow a rapid return to an organized heart rhythm, and thus restore effective spontaneous cardiac activity.
- Conditions
- Out-of-hospital Cardiac Arrest (OHCA)
- Being tested
- Potassium chloride
- Keywords
- Out-of-hospital cardiac arrest (OHCA), Potassium chloride, Refractory ventricular fibrillation, External electric shock, Defibrillation, Amiodarone, Lidocaine
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium chlorideDrug
Direct intravenous injection (IVD) 20 mmol potassium chloride
| Study group | Role | What they receive |
|---|---|---|
| Potassium chloride | Experimental | Potassium chloride Receives: Drug: Potassium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at hospital admission
Survival (return of spontaneous circulation) at hospital admission
Measured: At hospital admission up to 1 day
Secondary outcomes (9)
Number of pre-hospital return of spontaneous circulation (ROSC)
Return of spontaneous circulation in pre-hospital setting
Measured: Pre-hospital setting, up to 1 day
Time to pre-hospital return of spontaneous circulation (ROSC)
Time, in minutes, from cardiac arrest to return of spontaneous circulation in pre-hospital setting
Measured: Pre-hospital setting, up to 1 day
Total pre-hospital epinephrine dose
Total epinephrine dose in mg administered in the pre-hospital setting
Measured: Pre-hospital setting, up to 1 day
Total number of pre-hospital external electric shocks
Total number of external electric shocks delivered in the pre-hospital setting
Measured: Pre-hospital setting, up to 1 day
Total number of persistent or recurrent shockable rhythm disorders
Total number of persistent or recurrent rhythm disorders requiring an external electric shock in pre-hospital setting
Total number of persistent or recurrent rhythm disorders requiring an external electric shock in pre-hospital setting
Total number of persistent or recurrent rhythm disorders requiring an external electric shock in pre-hospital setting
Measured: Pre-hospital setting, up to 1 day
Heart rate at hospital admission
Measurement of heart rate when the patient arrives on the hospital ward
Measured: At hospital admission, up to 1 day
Blood pressure at hospital admission
Measurement of systolic and diastolic blood pressure when the patient arrives on the hospital ward
Measured: At hospital admission, up to 1 day
Survival with good neurological outcome (Cerebral Performance Category (CPC) 1 or 2)at hospital discharge
Survival with a good neurological prognosis (CPC scores 1 and 2) at hospital discharge
Measured: At hospital discharge, up to maximum 3 months
Survival with good neurological outcome (Cerebral Performance Category 1 or 2)at 3 months
Survival with a good neurological prognosis (CPC scores 1 and 2) at 3 months
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study startDec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: As the inclusion period in the study has ended and regulatory authorizations have expired on 26/12/2023, with no inclusions conducted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Out-of-hospital Cardiac Arrest (OHCA)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Romain Jouffroy, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316611
- Sponsor's protocol ID
- APHP180577
- Other IDs
- 2019-002544-24, 2019
- Acronym
- POTACREH
- Status last verified
- Oct 2025
- First submitted
- 7 Feb 2020
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jouffroy R, Ecollan P, Chollet-Xemard C, Prunet B, Elie C, Treluyer JM, Vivien B. Evaluation of the effectiveness of potassium chloride in the management of out-of hospital cardiac arrest by refractory ventricular fibrillation: Study protocol of the POTACREH study. PLoS One. 2023 Apr 12;18(4):e0284429. doi: 10.1371/journal.pone.0284429. eCollection 2023.
PubMed 37043520
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Potassium Chloride in the Management of Out-of-hospital Cardiac Arrest by Refractory Ventricular Fibrillation
- ClinicalTrials.gov ID
- NCT04316611
- Acronym / sponsor ID
- POTACREH / APHP180577
- Conditions
- Out-of-hospital Cardiac Arrest (OHCA)
- Keywords
- Out-of-hospital cardiac arrest (OHCA), Potassium chloride, Refractory ventricular fibrillation, External electric shock, Defibrillation, Amiodarone, Lidocaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: As the inclusion period in the study has ended and regulatory authorizations have expired on 26/12/2023, with no inclusions conducted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate, in patients presenting with out-of-hospital cardiac arrest (OHCA) by ventricular fibrillation, refractory to 3 external electric shocks, the efficacy of a direct intravenous injection of 20 mmol KCl on their survival at hospital arrival.
Detailed description
Out-of-hospital cardiac arrest (OHCA) has a poor prognosis, with an overall survival rate of about 5% at discharge. Shockable rhythm cardiac arrests (ventricular fibrillation (VF) and pulseless ventricular tachycardia) have a better prognosis.
In case of shockable rhythm, treatment is based on defibrillation, thereafter failure of 3 external electric shocks, on direct intravenous administration of 300 mg amiodarone, followed in case of ineffectiveness by an additional direct intravenous administration of 150 mg amiodarone. Lidocaine, which has long been used in this indication, is currently only recommended when amiodarone is unavailable or inefficient. Nevertheless, these 2 drugs, while they may be effective in converting refractory ventricular fibrillation to normal rhythm, have marked cardiodepressant effects (bradycardia, and/or negative inotropic effect) that persist after direct intravenous administration. This explains, at least partially, why a recent study did not show a significant difference in hospital discharge survival between amiodarone, lidocaine and placebo in patients presenting with OHCA by refractory ventricular fibrillation.
During surgical procedures under extracorporeal circulation, a cardioplegia solution is administered to interrupt cardiac activity and facilitate the surgical procedure. From a patho-physiological level, the mode of action of these solutions is based on a high concentration of potassium, which reduces the membrane resting potential of the myocytes. By extension, direct intravenous administration of 20 mmol potassium chloride (KCl) has been shown to convert ventricular fibrillation, resulting in a return to an hemodynamically efficient organized heart rate within a few minutes. The kalemia were at the upper limit of normal (5.5 mmol/l) 10 min after this injection, and normal at 20 min. A recent clinical case of a patient under extracorporeal circulation resuscitation, presenting with a refractory ventricular fibrillation, demonstrated the efficacy of direct intravenous injection of 3 g potassium chloride, resulting in a return to a sinus rhythm within a few minutes.
The immediate advantage of potassium chloride, compared to amiodarone (and also lidocaine), is the absence of cardiodepressant effect (bradycardia and/or hypotension) persisting after a while from the injection time. The mode of action of direct intravenous injection of potassium chloride to reduce ventricular fibrillation is indeed linked to the peak of hyperkalemia, whereas since the kalaemia are afterwards rapidly normalized in a few minutes, there is no persistent deleterious effect following this injection of potassium chloride. In addition, in the case of cardiac arrest, since the patient is already under continuous external cardiac chest compressions, no supplementary deleterious consequences related to this transient hyperkalemia are expected.
Direct intravenous injection of potassium chloride into a patient in out-of-hospital cardiac arrest with refractory ventricular fibrillation with 3 external electric shocks, instead of amiodarone, should interrupt this ventricular fibrillation and then allow a rapid return to an organized heart rhythm, and thus restore effective spontaneous cardiac activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Potassium chloride | Experimental | Drug: Potassium chloridePotassium chloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient (age 18 or over).
- Patient suffering from an outpatient cardiac arrest of presumed cardiac origin and presenting refractory ventricular fibrillation despite 3 external electric shocks.
- Patient with a health insurance plan.
Key exclusion criteria (3 listed)
- Proven pregnancy.
- Major incompetent (patient under guardianship or curatorship).
- Patient who does not yet have a functional venous pathway after the 3 external electric shocks have been performed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Potassium chlorideDirect intravenous injection (IVD) 20 mmol potassium chloride | Drug | Potassium chloride |
Primary outcome
Survival at hospital admission
Time frame: At hospital admission up to 1 day
Survival (return of spontaneous circulation) at hospital admission
9 secondary outcomes
Number of pre-hospital return of spontaneous circulation (ROSC)
Time frame: Pre-hospital setting, up to 1 day
Time to pre-hospital return of spontaneous circulation (ROSC)
Time frame: Pre-hospital setting, up to 1 day
Total pre-hospital epinephrine dose
Time frame: Pre-hospital setting, up to 1 day
Total number of pre-hospital external electric shocks
Time frame: Pre-hospital setting, up to 1 day
Total number of persistent or recurrent shockable rhythm disorders
Time frame: Pre-hospital setting, up to 1 day
Heart rate at hospital admission
Time frame: At hospital admission, up to 1 day
Blood pressure at hospital admission
Time frame: At hospital admission, up to 1 day
Survival with good neurological outcome (Cerebral Performance Category (CPC) 1 or 2)at hospital discharge
Time frame: At hospital discharge, up to maximum 3 months
Survival with good neurological outcome (Cerebral Performance Category 1 or 2)at 3 months
Time frame: At 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Derived from this study: PubMed 37043520Jouffroy R, Ecollan P, Chollet-Xemard C, Prunet B, Elie C, Treluyer JM, Vivien B. Evaluation of the effectiveness of potassium chloride in the management of out-of hospital cardiac arrest by refractory ventricular fibrillation: Study protocol of the POTACREH study. PLoS One. 2023 Apr 12;18(4):e0284429. doi: 10.1371/journal.pone.0284429. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romain Jouffroy, MD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Potassium chloride in people with Out-of-hospital Cardiac Arrest (OHCA), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival at hospital admission (time frame: At hospital admission up to 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04316611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.