Steroid, Thiamine and Ascorbic Acid for Comatose Out-of-hospital Cardiac Arrest Survivors

Phase 2

Recruiting

• Conditions: Out-Of-Hospital Cardiac Arrest; Postcardiac Arrest Syndrome

• Registration Number: NCT04921189
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-6-4
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Inclusion Criteria:<br><br> - An out-of-hospital cardiac arrest survivors treated with targeted temperature<br> management (target between 32 and 36 °C)<br><br> - Presumed cardiogenic cause as cardiac arrest<br><br>Exclusion Criteria:<br><br> - > 12 hours from cardiac arrest to drug or placebo administration<br><br> - previous poor neurological status (Cerebral Performance Categories 3 to 5)<br><br> - patients who have set limitations on treatment (e.g. patients with a signed<br> do-not-resuscitate order)<br><br> - Patients with an underlying terminal-stage disease without an active treatment plan<br> and those who are not expected to survive to discharge<br><br> - patients taking at least 1 g/day of vitamin C or receiving intravenous thiamine<br> prior to enrolment<br><br> - patients experiencing cardiac arrest prior to enrolment or who are expected to die<br> within 24 h despite best possible treatment, based on the judgement of medical<br> personnel<br><br> - pregnant women<br><br> - patients with glucose-6-phosphate dehydrogenase deficiency<br><br> - patients with a history of hypersensitivity reactions to the trial drugs<br><br> - patients with thalassemia<br><br> - patients with hyperoxaluria<br><br> - patients with cystinuria<br><br> - patients with ongoing gout attacks<br><br> - patients diagnosed with oxalate renal stones<br><br> - patients who do not voluntarily consent to participate in the trial (directly or by<br> legal proxy).

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the peak neuron-specific enolase level

Secondary Outcome Measures

Name	Time	Method
the delta neuron-specific enolase (NSE) level;The delta Sequential Organ Failure Assessment (SOFA) score;30-day Mortality;Time to death;In-hospital mortality;Intensive Care Unit (ICU) stay;7-day mortality;90-day mortality;180-day mortality;Time to Awakening;ICU free day;Hospital stay;Neurological outcome assessed using Cerebral Performance Category score;Neurological outcome assessed using the modified Rankin Scale