CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 158 enrolled
Drug / intervention
Methylprednisolone +1 moredrug
Likely dose
Methylprednisolone 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04624776
NCT04624776Phase 2Completed
CompareCT.gov

Steroid Treatment as Anti-inflammatory and Neuroprotective Agent Following Out-of-Hospital Cardiac Arrest. A Randomized Trial

Christian Hassager·interventional·Posted Nov 12, 2020·Updated Mar 29, 2023

In Brief

A Phase 2 clinical trial evaluating Methylprednisolone and Isotonic saline for Out-Of-Hospital Cardiac Arrest and 5 related conditions. Completed, enrolled 158 participants across 2 sites.

Detailed Summary

Comatose patients resuscitated from Out-of-Hospital Cardiac Arrest (OHCA) often develop a complicated systemic inflammatory response and have a poor prognosis with neurological damage being the most common cause of death. This study will investigate the anti-inflammatory and neuroprotective effect of early treatment with the glucocorticoid methylprednisolone measured by interleukin-6 and neuron-specific enolase levels in resuscitated comatose OHCA-patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOut-Of-Hospital Cardiac Arrest, Cardiac Arrest, Cardiac Arrest With Successful Resuscitation, Post Cardiac Arrest Syndrome, Systemic Inflammatory Response Syndrome, Neurological Injury
CountriesDenmark
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedNov 12, 2020
Enrollment StartOct 10, 2020
Primary CompletionJul 15, 2022
Study CompletionFeb 28, 2023
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 5.6 years ago

Interventions

Methylprednisolonedrug

A dosis of 250 mg methylprednisolone is suspended in isotonic saline to a total volume of 4 mL prior to infusion.

Isotonic salinedrug

A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).