---
title: Potassium Chloride in Out-of-hospital Cardiac Arrest Due to Refractory Ventricular Fibrillation
nct_id: NCT04316611
overall_status: WITHDRAWN
phase: PHASE2
sponsor: Assistance Publique - Hôpitaux de Paris
study_type: INTERVENTIONAL
primary_condition: Out-of-hospital Cardiac Arrest (OHCA)
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04316611.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04316611"
ct_last_update_post_date: 2025-11-20
last_seen_at: "2026-05-12T07:21:25.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Potassium Chloride in Out-of-hospital Cardiac Arrest Due to Refractory Ventricular Fibrillation

**Official Title:** Evaluation of the Effectiveness of Potassium Chloride in the Management of Out-of-hospital Cardiac Arrest by Refractory Ventricular Fibrillation

**NCT ID:** [NCT04316611](https://clinicaltrials.gov/study/NCT04316611)

## Key Facts

- **Status:** WITHDRAWN
- **Why Stopped:** As the inclusion period in the study has ended and regulatory authorizations have expired on 26/12/2023, with no inclusions conducted.
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 0
- **Lead Sponsor:** Assistance Publique - Hôpitaux de Paris
- **Collaborators:** URC-CIC Paris Descartes Necker Cochin
- **Conditions:** Out-of-hospital Cardiac Arrest (OHCA)
- **Start Date:** 2023-12
- **Completion Date:** 2024-12
- **CT.gov Last Update:** 2025-11-20

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Potassium chloride** (EXPERIMENTAL) — Potassium chloride

## Interventions

- **Potassium chloride** (DRUG) — Direct intravenous injection (IVD) 20 mmol potassium chloride

## Primary Outcomes

- **Survival at hospital admission** _(time frame: At hospital admission up to 1 day)_ — Survival (return of spontaneous circulation) at hospital admission

## 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)_

## Locations (1)

- AP-HP - SAMU de Paris, Paris, France

## Recent Field Changes (last 30 days)

- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ap-hp - samu de paris|paris||france` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT04316611*  
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