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

Primary Purpose

Out-of-hospital Cardiac Arrest (OHCA)

Status
Not yet recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Potassium chloride
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Out-of-hospital Cardiac Arrest (OHCA) focused on measuring Out-of-hospital cardiac arrest (OHCA), Potassium chloride, Refractory ventricular fibrillation, External electric shock, Defibrillation, Amiodarone, Lidocaine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AP-HP - SAMU de Paris

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Potassium chloride

Arm Description

Potassium chloride

Outcomes

Primary Outcome Measures

Survival at hospital admission
Survival (return of spontaneous circulation) at hospital admission

Secondary Outcome Measures

Number of pre-hospital return of spontaneous circulation (ROSC)
Return of spontaneous circulation in pre-hospital setting
Time to pre-hospital return of spontaneous circulation (ROSC)
Time, in minutes, from cardiac arrest to return of spontaneous circulation in pre-hospital setting
Total pre-hospital epinephrine dose
Total epinephrine dose in mg administered in the pre-hospital setting
Total number of pre-hospital external electric shocks
Total number of external electric shocks delivered in the pre-hospital setting
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
Heart rate at hospital admission
Measurement of heart rate when the patient arrives on the hospital ward
Blood pressure at hospital admission
Measurement of systolic and diastolic blood pressure when the patient arrives on the hospital ward
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
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

Full Information

First Posted
February 7, 2020
Last Updated
February 2, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
URC-CIC Paris Descartes Necker Cochin
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1. Study Identification

Unique Protocol Identification Number
NCT04316611
Brief Title
Potassium Chloride in Out-of-hospital Cardiac Arrest Due to Refractory Ventricular Fibrillation
Acronym
POTACREH
Official Title
Evaluation of the Effectiveness of Potassium Chloride in the Management of Out-of-hospital Cardiac Arrest by Refractory Ventricular Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
URC-CIC Paris Descartes Necker Cochin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-of-hospital Cardiac Arrest (OHCA)
Keywords
Out-of-hospital cardiac arrest (OHCA), Potassium chloride, Refractory ventricular fibrillation, External electric shock, Defibrillation, Amiodarone, Lidocaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Potassium chloride
Arm Type
Experimental
Arm Description
Potassium chloride
Intervention Type
Drug
Intervention Name(s)
Potassium chloride
Intervention Description
Direct intravenous injection (IVD) 20 mmol potassium chloride
Primary Outcome Measure Information:
Title
Survival at hospital admission
Description
Survival (return of spontaneous circulation) at hospital admission
Time Frame
At hospital admission up to 1 day
Secondary Outcome Measure Information:
Title
Number of pre-hospital return of spontaneous circulation (ROSC)
Description
Return of spontaneous circulation in pre-hospital setting
Time Frame
Pre-hospital setting, up to 1 day
Title
Time to pre-hospital return of spontaneous circulation (ROSC)
Description
Time, in minutes, from cardiac arrest to return of spontaneous circulation in pre-hospital setting
Time Frame
Pre-hospital setting, up to 1 day
Title
Total pre-hospital epinephrine dose
Description
Total epinephrine dose in mg administered in the pre-hospital setting
Time Frame
Pre-hospital setting, up to 1 day
Title
Total number of pre-hospital external electric shocks
Description
Total number of external electric shocks delivered in the pre-hospital setting
Time Frame
Pre-hospital setting, up to 1 day
Title
Total number of persistent or recurrent shockable rhythm disorders
Description
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
Time Frame
Pre-hospital setting, up to 1 day
Title
Heart rate at hospital admission
Description
Measurement of heart rate when the patient arrives on the hospital ward
Time Frame
At hospital admission, up to 1 day
Title
Blood pressure at hospital admission
Description
Measurement of systolic and diastolic blood pressure when the patient arrives on the hospital ward
Time Frame
At hospital admission, up to 1 day
Title
Survival with good neurological outcome (Cerebral Performance Category (CPC) 1 or 2)at hospital discharge
Description
Survival with a good neurological prognosis (CPC scores 1 and 2) at hospital discharge
Time Frame
At hospital discharge, up to maximum 3 months
Title
Survival with good neurological outcome (Cerebral Performance Category 1 or 2)at 3 months
Description
Survival with a good neurological prognosis (CPC scores 1 and 2) at 3 months
Time Frame
At 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benoît Vivien, MD, PhD
Phone
+33 1 44 49 23 67
Email
benoit.vivien@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nelly Briand, PhD
Phone
+33 1 44 38 18 62
Email
nelly.briand@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romain Jouffroy, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
AP-HP - SAMU de Paris
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoît Vivien, MD, PhD
Phone
+33 1 44 49 23 67
Email
benoit.vivien@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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