Potassium Chloride in Out-of-hospital Cardiac Arrest Due to Refractory Ventricular Fibrillation

NCT ID: NCT04316611

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2024-12-31

Brief 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.

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Potassium chloride

Potassium chloride

Group Type: EXPERIMENTAL

Potassium chloride

Intervention Type: DRUG

Direct intravenous injection (IVD) 20 mmol potassium chloride

Interventions

Potassium chloride

Direct intravenous injection (IVD) 20 mmol potassium chloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Romain Jouffroy, MD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

AP-HP - SAMU de Paris

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 37043520 (View on PubMed)

Other Identifiers

2019-002544-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

APHP180577

Identifier Type: -

Identifier Source: org_study_id