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CYclosporine A in Shockable Out-of-hospital Cardiac Arrest ResUScitation

NCT02887807 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2019-03-14

No results posted yet for this study

Summary

Cardiac arrest (CA) is a public health problem in industrialized countries. The prognosis of these patients remains poor with significant mortality and severe neurological sequelae in survivors.

The objective of the present study is to determine whether cyclosporine can improve patient clinical outcome after shockable CA. 520 patients with CA will be entered into a multicentre, randomized, placebo-controlled study. They will receive one single injection of cyclosporine (or placebo) prior to resuscitation. The incidence of the combined endpoint (mortality, irreversible brain damage informations such as bilateral abolition of N20 wave or absent motor response or extension to the nociceptive stimulation…) will be assessed 7 days after CA.

Conditions

  • Shockable Out of Hospital Cardiac Arrest

Interventions

DRUG

Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation

cardio-pulmonary resuscitation usual care of cardiac arrest

DRUG

Single intravenous bolus of placebo at the onset of resuscitation

cardio-pulmonary resuscitation usual care of cardiac arrest

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Laurent Argaud · Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02887807 on ClinicalTrials.gov