NCT02225561

Brief Summary

Approximately 50,000 patients are victims of out of hospital cardiac arrest every year in France. Despite cardiopulmonary resuscitation (CPR) and many studies on the topic resuscitation survival after cardiac arrest remains low (1-8%) and has not changed significantly over the past five decades.It has recently been shown that the combination of different non-invasive therapies, cardiopulmonary resuscitation with mechanical CPR with automated compression / decompression and an impedance threshold device, can increase the rate of return of spontaneous circulation and short and long term survival after cardiac arrest.We propose to study a new cardiopulmonary resuscitation called SNPeCPR (Sodium nitroprusside enhanced cardiopulmonary resuscitation), which includes two components:a) a mechanical component: cardiopulmonary resuscitation with automated mechanical external chest compression and an impedance threshold deviceb) a pharmacological component: sodium nitroprusside, an effective arterial vasodilator that decrease vascular resistance, and improve flow in vital organs.Our hypothesis is that SNPeCPR should improve the return of spontaneous circulation rate during cardiac arrest.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2015

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

January 2, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2018

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

2.5 years

First QC Date

August 25, 2014

Last Update Submit

January 8, 2020

Conditions

Cardiopulmonary Arrest

Keywords

Cardiopulmonary resuscitationNitroprussideTransthoracicImpedances

Outcome Measures

Primary Outcomes (1)

  • Rate of return of spontaneous circulation (ROSC)

    Rate of return of spontaneous circulation (ROSC) defined as a central pulse (carotid or femoral) palpable for more than 5 minutes

    at 5 minutes

Secondary Outcomes (11)

  • ETCO2

    at 0, 5 and 60 minutes

  • Blood pressure

    at 5 and 60 min

  • ECG

    at 0, 5 and 60 minutes

  • SpO2

    at 0, 5 and 60 minutes

  • Arterial blood gases with lactate

    at 0 and 5 minutes; 1, 4 and 24 hours

  • +6 more secondary outcomes

Study Arms (2)

Intervention arm

EXPERIMENTAL

Pharmaco- mechanical optimization

Procedure: pharmaco- mechanical optimization

Mechanical optimization only

ACTIVE COMPARATOR

Mechanical optimization only

Procedure: mechanical optimization only

Interventions

pharmaco- mechanical optimizationPROCEDURE

Getting started as soon as possible cardiopulmonary resuscitation (CPR) mechanical ( LUCAS 2) with inspiratory impedance valve ( ResQPOD ) performed according to the 2015 recommendations of the European Resuscitation Council . It will be carried out continuously without a break for control pulse until the first defibrillation attempt. As soon the peripheral intravenous or intraosseous line is set the intervention group will receive an injection of 2 mg of sodium nitroprusside. 4 minutes after the first injection, a second and last injection of 1 mg of sodium nitroprusside will be realized.- The preparation procedure of the sodium nitroprusside will be: * Using a "pomping needle" and the provided syringe 4 ml of the solvent (Water for Injections, WFI) will be take. * The 4 ml of WFI will be empty in the 50 mg vial of lyophilisate sodium nitroprusside to solubilize the product. * Always with the needle and 20 ml syringe, the 4 ml of this solution (50 mg in 4 ml) will be collect.

Intervention arm
mechanical optimization onlyPROCEDURE

Getting started as soon as possible cardiopulmonary resuscitation (CPR) mechanical ( LUCAS 2) with inspiratory impedance valve ( ResQPOD ) performed according to the 2015 recommendations of the European Resuscitation Council . It will be carried out continuously without a break for control pulse until the first defibrillation attempt.

Mechanical optimization only

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with out of hospital cardiac arrest
  • Age\> 18 years and \<75 years
  • Initial Rhythm: Ventricular fibrillation or ventricular tachycardia or pulseless electrical activity

You may not qualify if:

  • out of hospital cardiac arrest of non-cardiac origin:
  • trauma
  • anoxic, including drowning
  • hemorrhage,
  • overdose (drugs),
  • drug,
  • electric
  • Do Not Resuscitate Order,
  • obvious signs of clinical death (decomposition, cadaveric rigidity, decapitation)
  • recent sternotomy (\<6 months or recent scar)
  • Contraindications related to sodium nitroprusside
  • Women of childbearing age (between 18 and 55 years)
  • Other contra-indications will usually not known during resuscitation in case of presence of a relative rescue team must be searched: Hypothyroidism, Sulfuryl transferase deficiency (rhodanese Lang) currently recognized in patients with Leber optic atrophy, tobacco amblyopia or severe hepatic impairment.
  • Obesity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMUR - Hôpital Lariboisière

Paris, 75010, France

Location

Related Publications (4)

  • Schultz J, Segal N, Kolbeck J, Caldwell E, Thorsgard M, McKnite S, Aufderheide TP, Lurie KG, Yannopoulos D. Sodium nitroprusside enhanced cardiopulmonary resuscitation prevents post-resuscitation left ventricular dysfunction and improves 24-hour survival and neurological function in a porcine model of prolonged untreated ventricular fibrillation. Resuscitation. 2011 Dec;82 Suppl 2(0 2):S35-40. doi: 10.1016/S0300-9572(11)70149-6.

    PMID: 22208176BACKGROUND

  • Schultz J, Segal N, Kolbeck J, McKnite S, Caldwell E, Yannopoulos D. Sodium nitroprusside enhanced cardiopulmonary resuscitation (SNPeCPR) improves vital organ perfusion pressures and carotid blood flow in a porcine model of cardiac arrest. Resuscitation. 2012 Mar;83(3):374-7. doi: 10.1016/j.resuscitation.2011.07.038. Epub 2011 Aug 22.

    PMID: 21864483BACKGROUND

  • Schultz JC, Segal N, Caldwell E, Kolbeck J, McKnite S, Lebedoff N, Zviman M, Aufderheide TP, Yannopoulos D. Sodium nitroprusside-enhanced cardiopulmonary resuscitation improves resuscitation rates after prolonged untreated cardiac arrest in two porcine models. Crit Care Med. 2011 Dec;39(12):2705-10. doi: 10.1097/CCM.0b013e31822668ba.

    PMID: 21725236BACKGROUND

  • Yannopoulos D, Matsuura T, Schultz J, Rudser K, Halperin HR, Lurie KG. Sodium nitroprusside enhanced cardiopulmonary resuscitation improves survival with good neurological function in a porcine model of prolonged cardiac arrest. Crit Care Med. 2011 Jun;39(6):1269-74. doi: 10.1097/CCM.0b013e31820ed8a6.

    PMID: 21358401BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Patrick PLAISANCE, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2014

First Posted

August 26, 2014

Study Start

January 2, 2015

Primary Completion

July 2, 2017

Study Completion

January 2, 2018

Last Updated

January 10, 2020

Record last verified: 2020-01

Locations

FR(1)