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

Interleukin-6 Receptor Antibodies for Modulating the Systemic Inflammatory Response after Out-of-Hospital Cardiac Arrest - IL-6 inhibition for modulating inflammation after cardiac arrest

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002686-19-DK

Enrollment

Registered

2018-08-10

Start date

2018-11-07

Completion date

Unknown

Last updated

2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 20.0 Level: PT Classification code 10007515 Term: Cardiac arrest System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: RoActemra Product Name: RoActemra Product Code: EU/1/08/492/006 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Tocilizumab, RoActemra CAS Number: 375823-41-9 Other descrip

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 240 minutes from ROSC to randomization 12) Known allergies to IL-6RA 13) Known infection 14) Known hepatic cirrhosis

Design outcomes

Primary

Measure	Time frame
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. ;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	—

Measure

Time frame

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. ;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

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Secondary

Measure	Time frame
Secondary end point(s): Markers of inflammation: Daily interleukin levels (IL-1b, IL-6, IL-10, IL-13, TNF-a) from admission to 72 hours after admission Daily differential count the first 3 days from admission Daily Sequential Organ Failure Assessment (SOFA) scores the first 3 days from admission Markers of cardiac injury: Daily troponin T (TnT) and CKMB levels the first 3 days from admission Markers of hemodynamic function: Daily Swan-Ganz based measurements of cardiac output, central venous pressure, pulmonary capillary wedge pressure, and systemic vascular resistance Bihourly analyses of arterial blood gas the first 36 hours Markers of cerebral injury: Neuron-specific enolase (NSE) levels after 48 and 72 hours Markers of kidney injury: Daily creatinine levels the first 3 days from admission Markers of hepatic injury: Daily measurements of ALAT, ASAT, bilirubin, INR the first 3 days from admission Markers of endothelial injury: Daily soluble thrombomodulin levels the first 3 days from admission Clinical endpoints: Survival at 30 days, 90 days, 180 days, and at end of trial Montreal Cognitive Assessment (MOCA) score at 90 days Cerebral Performance Category (CPC) at 30 days, 90 days and 180 days Safety: Cumulated incidence of adverse events the first 7 days ;Timepoint(s) of evaluation of this end point: Evaluation of paraclinical endpoints (markers of organ dysfunction) up to three days after admission. Evaluation of clinical endpoints (survival/function) finished 180 days after admission.	—

Measure

Time frame

Secondary end point(s): Markers of inflammation: Daily interleukin levels (IL-1b, IL-6, IL-10, IL-13, TNF-a) from admission to 72 hours after admission Daily differential count the first 3 days from admission Daily Sequential Organ Failure Assessment (SOFA) scores the first 3 days from admission Markers of cardiac injury: Daily troponin T (TnT) and CKMB levels the first 3 days from admission Markers of hemodynamic function: Daily Swan-Ganz based measurements of cardiac output, central venous pressure, pulmonary capillary wedge pressure, and systemic vascular resistance Bihourly analyses of arterial blood gas the first 36 hours Markers of cerebral injury: Neuron-specific enolase (NSE) levels after 48 and 72 hours Markers of kidney injury: Daily creatinine levels the first 3 days from admission Markers of hepatic injury: Daily measurements of ALAT, ASAT, bilirubin, INR the first 3 days from admission Markers of endothelial injury: Daily soluble thrombomodulin levels the first 3 days from admission Clinical endpoints: Survival at 30 days, 90 days, 180 days, and at end of trial Montreal Cognitive Assessment (MOCA) score at 90 days Cerebral Performance Category (CPC) at 30 days, 90 days and 180 days Safety: Cumulated incidence of adverse events the first 7 days ;Timepoint(s) of evaluation of this end point: Evaluation of paraclinical endpoints (markers of organ dysfunction) up to three days after admission. Evaluation of clinical endpoints (survival/function) finished 180 days after admission.

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Countries

Denmark

Contacts

Public ContactDepartment of Cardiology

Copenhagen University Hospital Rigshospitalet

christian.hassager@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 25, 2026