sing the medicine 'interleukin-6 receptor antagonists' to inhibit the inflammation in patients resuscitated from cardiac arrest.

Phase 1

• Conditions: We investigate the efficacy of commercially available interleukin-6 receptor antibody 'RoActemra' for reducing the systemic inflammatory response in patients having been resuscitated after out-of-hospital cardiac arrest. This study is a double-blind, randomized pilot trial.; MedDRA version: 20.0Level: PTClassification code 10007515Term: Cardiac arrestSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-002686-19-DK
• Lead Sponsor: Department of Cardiology, Copenhagen University Hospital Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-10
• Last Update Posted: 19 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1)Age = 18 years
2)Out-of-hospital cardiac arrest of a presumed cardiac cause
3)Unconsciousness upon admission
4)Sustained return of spontaneous circulation for more than 20 minutes

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

1)Consciousness upon admission
2)Presumed non-cardiac cause of arrest
3)Unwitnessed asystole
4)Suspected or confirmed intracranial bleeding or stroke
5)Pregnancy, or females in fertile age, unless a negative serum HCG can rule out pregnancy within the inclusion window.
6)Temperature on admission < 30 °C
7)Persistent cardiogenic shock that is not reversed within the inclusion window
8)Known disease making 180 day survival unlikely
9)Known limitations in therapy
10)Known pre-arrest Cerebral Performance Category of 3 to 4
11) > 240 minutes from ROSC to randomization
12) Known allergies to IL-6RA
13) Known infection
14) Known hepatic cirrhosis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to determine the efficacy of an IL-6 receptor antibody (IL-6RA) compared with placebo on the endpoint of daily high-sensitivity c-reactive protein (hsCRP) measurements from admission (i.e. prior to initiation of study drug) to the first 72 hours after admission in patients admitted after resuscitated OHCA. <br>;Secondary Objective: The secondary objectives of this study are to determine the effects of an IL-6RA on inhibition of inflammation, cardiac protection, neuroprotection, renal protection, endothelial protection, clinical endpoints including survival and neurological outcome, as well as safety.;Primary end point(s): Daily measurements of hsCRP from admission to 72 hours after admission;Timepoint(s) of evaluation of this end point: hsCRP will be measured daily from admission to 3 days after admission