Out-Of-Hospital Cardiac Arrest Clinical Trial
— IMICAOfficial title:
Interleukin-6 Receptor Antibodies for Modulating the Systemic Inflammatory Response After Out-of-Hospital Cardiac Arrest - a Randomized Clinical Trial
Verified date | August 2020 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | June 30, 2020 |
Est. primary completion date | December 23, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Each of the following criteria must be fulfilled for a subject to be eligible: 1. Age = 18 years 2. OHCA of a presumed cardiac cause 3. Unconsciousness upon admission, i.e. a GCS < 9 4. Sustained ROSC for more than 20 minutes Exclusion Criteria: None of the following criteria must be fulfilled for a subject to be eligible: 1. Consciousness upon admission, i.e. a GCS = 9 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Christian Hassager |
Denmark,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Predefined sub-study: MRI of heart and brain | A subset of the trial participants will be enrolled in a sub-study focusing on cardio protection and neuroprotection as a pilot investigation. This sub-study will include an echocardiography, a cerebral MR scan and a cardiac MR scan; all three modalities being performed the day following admission. | The day following admission. | |
Primary | Concentration of hsCRP | high sensitivity C-reactive protein | Daily measurements from admission to 72 hours after admission. | |
Secondary | Biomarkers of organ damage | Markers of cerebral injury: Neuron-specific enolase (NSE) levels (routine biochemistry), and other markers of cerebral injury (analysis of samples in biobank). Markers of cardiac injury: Troponin T (TnT) and CKMB levels. Markers of kidney injury: Creatinine levels. Markers of hepatic injury: ALAT, ASAT, bilirubin, INR. Markers of endothelial injury: soluble thrombomodulin levels. |
Plasma/serum samples and routine biochemistry are collected at admission, 24h, 48h and 72h (NSE only at 48 and 72h) | |
Secondary | Markers of inflammation, interleukin levels | Interleukin levels: INF-g, IL-1b, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8 IL-10, IL-12, IL-13, IL-17A, G-CSF, GM-CSF, MCP-1 og MIP-1beta and TNF-a (analysis of samples in biobank). | At admission, 24h, 48h & 72h | |
Secondary | Markers of inflammation, leukocytes | Leukocyte differential count. | At admission, 24h, 48h & 72h | |
Secondary | Markers of inflammation, SOFA score | Daily Sequential Organ Failure Assessment (SOFA) scores. | The first 3 days from admission | |
Secondary | Markers of the coagulation system, fibrinogen | The possible downstream effect of dampened inflammation on the coagulation system is evaluated by the concentration of plasma-fibrinogen. | At admission, 48h and 72h | |
Secondary | Markers of the coagulation system, thrombelastography | The possible downstream effect of dampened inflammation on the coagulation system is evaluated by whole blood thrombelastography. | At admission and 48h | |
Secondary | Markers of hemodynamic function, Swan-Ganz Catheter | Swan-Ganz based measurements of cardiac output, central venous pressure, pulmonary capillary wedge pressure, and systemic vascular resistance. | At admission, 24h, 48h & 72h | |
Secondary | Markers of hemodynamic function, Arterial blood gasses | Arterial blood gasses including lactate and base excess at frequent intervals. | At admission, 2h, 4h, 6h, 8h, 10h, 12h, 18h, 24h, 30h, 36h, 48h, 72h, 96h and 120h (sampling ceases if the arterial line is discontinued). | |
Secondary | Markers of hemodynamic function, Echocardiography | Transthoracic echocardiography including assesment of left ventricular ejection fraction (LVEF) and tricuspid annular plane systolic excursion (TAPSE). | Day 1 and on either day 3, 4 or 5. | |
Secondary | Clinical endpoints, Survival | Survival. | At 30 days, 90 days, 180 days, and at end of trial. | |
Secondary | Clinical endpoints, MOCA score | Montreal Cognitive Assessment (MOCA) score at 90 days. | At 90 days. | |
Secondary | Clinical endpoints, CPC | Cerebral Performance Category (CPC) at 30 days, 90 days and 180 days, assessed by telephone interview and/or review of medical file after completion of the 180 days. | At 30 days, 90 days and 180 days. | |
Secondary | Safety: incidence of adverse events | Cumulated incidence of adverse events the first 7 days. | From admission till 7 days. |
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