IL-6 Inhibition for Modulating Inflammation After Cardiac Arrest

Sponsor
Christian Hassager
Study ID
NCT03863015
Phase
PHASE2
Status
Completed

Conditions

  • Heart Arrest
  • Out-Of-Hospital Cardiac Arrest
  • Systemic Inflammatory Response Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab 20 Mg/mL Intravenous Solution — DRUG
    Tocilizumab is suspended in isotonic saline to a total volume of 100mL prior to infusion
  • isotonic saline — DRUG
    A one hour infusion of 100mL isotonic saline

Study Details

Resuscitated cardiac arrest is associated with a systemic inflammatory response that is directly associated with poor prognosis. Inhibition of the IL-6 mediated immune response may potentially inhibit the systemic inflammatory response, potentially improving the prognosis of these severely ill patients.

Key Dates

Start date
Mar 4, 2019
Status verified
Aug 2020
Primary completion
Dec 23, 2019
Completion
Jun 30, 2020

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Tocilizumab
    A one hour infusion of a single 8mg/kg dose (max. 800mg) of tocilizumab to attenuate systemic inflammation after out-of-hospital cardiac arrest, given as early as possible after hospital admission.
  • Placebo Comparator: Isotonic saline
    A one hour infusion of isotonic saline

Primary Outcome Measure

Concentration of hsCRP [ Time Frame: Daily measurements from admission to 72 hours after admission. ]

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