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

NCT04316611 | Withdrawn Phase 2 DMC

• 2 other identifiers: APHP1805772019-002544-24
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Survival at hospital admission

  Survival (return of spontaneous circulation) at hospital admission

  At hospital admission up to 1 day

Secondary Outcomes (9)

• Number of pre-hospital return of spontaneous circulation (ROSC)

  Pre-hospital setting, up to 1 day

• Time to pre-hospital return of spontaneous circulation (ROSC)

  Pre-hospital setting, up to 1 day

• Total pre-hospital epinephrine dose

  Pre-hospital setting, up to 1 day

• Total number of pre-hospital external electric shocks

  Pre-hospital setting, up to 1 day

• Total number of persistent or recurrent shockable rhythm disorders

  Pre-hospital setting, up to 1 day

Study Arms (1)

Potassium chloride

EXPERIMENTAL

Potassium chloride

Drug: Potassium chloride

Interventions

Potassium chloride DRUG

Direct intravenous injection (IVD) 20 mmol potassium chloride

Potassium chloride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

AP-HP - SAMU de Paris

Paris, 75015, France

Location

Related Publications (1)

• 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.

  PMID: 37043520 DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Ventricular Fibrillation

Interventions

Potassium Chloride

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Potassium Compounds

Study Officials

• Romain Jouffroy, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: March 20, 2020
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)