USING STEROID TREATMENT TO INHIBIT INFLAMMATION AND BRAIN INJURY IN PATIENTS RESUSCITATED FROM CARDIAC ARREST.

STEROID TREATMENT AS ANTI-INFLAMMATORY AND NEUROPROTECTIVE AGENT FOLLOWING OUT-OF-HOSPITAL CARDIAC ARREST. A RANDOMIZED TRIAL. - STEROID TREATMENT FOR OHCA PATIENTS

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000855-11-DK

Enrollment

120

Registered

2020-03-30

Start date

2020-09-11

Completion date

Unknown

Last updated

2020-09-28

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 glucocorticoid "methylprednisolone" (Solu-Medrol) for reducing the systemic inflammatory response and neurological injury in patients resuscitated after out-of-hospital cardiac arrest. MedDRA version: 20.0 Level: LLT Classification code 10003109 Term: Arrest cardiac System Organ Class: 100000004849

Interventions

Trade Name: Solu-Medrol Product Name: Solu-medrol Product Code: 6132 Pharmaceutical Form: Solution for injection INN or Proposed INN: Methylprednisolone Other descriptive name: METHYLPREDNISOLONE SODI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. OHCA of presumed cardiac cause 3. Unconsciousness (GCS =8) upon pre-hospital randomization 4. Sustained ROSC for at least 5 minutes 5. Randomization within 30 minutes of sustained ROSC 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80

Exclusion criteria

Exclusion criteria: 1. Advanced life support TOR exclusion criteria 2. Asystole as primary ECG rhythm 3. Female of child bearing potential (female aged 15-40, decided by the treating physician) 4. Known therapy limitation (known decision made of no resuscitation or intensive therapy) 5. Known allergy to glucocorticoid 6. Known disease making 180-day survival unlikely 7. Known pre-arrest modified Rankin Scale (mRS) score of 4-5 8. Temperature upon admission 30 minutes to sustained ROSC

Design outcomes

Primary

Measure	Time frame
Primary end point(s): The anti-inflammatory and neuroprotective effect of methylprednisolone decided by measurements of IL-6 and NSE at admission and 24, 48 and 72 hours after admission. ;Main Objective: The primary objective of this study is to determine the efficacy of the glucocorticoid "methylprednisolone" (Solu-Medrol) compared with placebo. The co-primary endpoints being serial measurements of interleukin-6 (IL-6) and neuron-specific-enolase (NSE) at admission and 24, 48 and 72 hours after admission in patients admitted after resuscitated OHCA.;Secondary Objective: The secondary objectives of this study are to determine the effects of the glucocorticoid "methylprednisolone" (Solu-Medrol) on inhibition of inflammation, cardiac protection, neuroprotection, renal protection, endothelial protection, clinical endpoints including survival and neurological outcome, as well as safety.;Timepoint(s) of evaluation of this end point: At admission and 24, 48 and 72 hours after admission.	—

Measure

Time frame

Primary end point(s): The anti-inflammatory and neuroprotective effect of methylprednisolone decided by measurements of IL-6 and NSE at admission and 24, 48 and 72 hours after admission. ;Main Objective: The primary objective of this study is to determine the efficacy of the glucocorticoid "methylprednisolone" (Solu-Medrol) compared with placebo. The co-primary endpoints being serial measurements of interleukin-6 (IL-6) and neuron-specific-enolase (NSE) at admission and 24, 48 and 72 hours after admission in patients admitted after resuscitated OHCA.;Secondary Objective: The secondary objectives of this study are to determine the effects of the glucocorticoid "methylprednisolone" (Solu-Medrol) on inhibition of inflammation, cardiac protection, neuroprotection, renal protection, endothelial protection, clinical endpoints including survival and neurological outcome, as well as safety.;Timepoint(s) of evaluation of this end point: At admission and 24, 48 and 72 hours after admission.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Markers of inflammation: High sensitivity C-reactive protein (hsCRP), leucocyte- and differential count, plasma cytokine levels (IL-1b, IL-2, IL-4, IL-5, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17A, G-CSF, GM-CSF, MCP-1, MIP-1beta, INF-g and tumor-necrosis factor a (TNF-a)) and procalcitonin measured daily the first three days following admission. 2. Markers of kidney and hepatic injury: Daily creatinine levels the first three days from admission. Daily measurements of ALAT, ASAT, BF, bilirubin and INR the first three days from admission. 3. Markers of the coagulation system: Plasma fibrinogen the first three days from admission, and thromboelastography at admission and at 48 hours. 4. Protein and enzymatic protection: Daily proteomics and metabolomics samples the first three days from admission. 5. Hemodynamics: Daily evaluation by Swan-Ganz catheter, bihourly analyses of arterial blood gases the first 36 hours and transthoracic echocardiogram (TTE) measured the day following admission and on either day 3, 4 or 5. 6. Neuroprotection: Daily measurements of TAU, NFL, NFM, NFH and GFAP levels the first three days from admission. Formation of cerebral edema decided by MR-imaging of the brain after regained consciousness and consent. 7. Cardiac protection: Daily measurements of TnT, TnI and CKMB levels the first three days from admission. Infarct size decided by MR-imaging after regained consciousness and consent before discharge from the primary hospital. 8. Respiratory protection: Lung UltraSound (LUS) performed the day following admission and on either day 3, 4 or 5. 9. Clinical endpoints: Survival and neurological outcome, decided by mRS score after five days, at discharge from the intensive ward and the hospital and further at 30- and 180- days following discharge through telephone interview. 10. Follow-up at 90 days following discharge in an ambulatory setting: MoCA-score for assessment of cognitive function and patients will be screened	—

Measure

Time frame

Secondary end point(s): 1. Markers of inflammation: High sensitivity C-reactive protein (hsCRP), leucocyte- and differential count, plasma cytokine levels (IL-1b, IL-2, IL-4, IL-5, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17A, G-CSF, GM-CSF, MCP-1, MIP-1beta, INF-g and tumor-necrosis factor a (TNF-a)) and procalcitonin measured daily the first three days following admission. 2. Markers of kidney and hepatic injury: Daily creatinine levels the first three days from admission. Daily measurements of ALAT, ASAT, BF, bilirubin and INR the first three days from admission. 3. Markers of the coagulation system: Plasma fibrinogen the first three days from admission, and thromboelastography at admission and at 48 hours. 4. Protein and enzymatic protection: Daily proteomics and metabolomics samples the first three days from admission. 5. Hemodynamics: Daily evaluation by Swan-Ganz catheter, bihourly analyses of arterial blood gases the first 36 hours and transthoracic echocardiogram (TTE) measured the day following admission and on either day 3, 4 or 5. 6. Neuroprotection: Daily measurements of TAU, NFL, NFM, NFH and GFAP levels the first three days from admission. Formation of cerebral edema decided by MR-imaging of the brain after regained consciousness and consent. 7. Cardiac protection: Daily measurements of TnT, TnI and CKMB levels the first three days from admission. Infarct size decided by MR-imaging after regained consciousness and consent before discharge from the primary hospital. 8. Respiratory protection: Lung UltraSound (LUS) performed the day following admission and on either day 3, 4 or 5. 9. Clinical endpoints: Survival and neurological outcome, decided by mRS score after five days, at discharge from the intensive ward and the hospital and further at 30- and 180- days following discharge through telephone interview. 10. Follow-up at 90 days following discharge in an ambulatory setting: MoCA-score for assessment of cognitive function and patients will be screened

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Countries

Denmark

Contacts

Public ContactDepartment of Cardiology

Copenhagen University Hospital Rigshospitalet

christian.hassager@regionh.dk4535450572

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026