Antioxidant and NMDA Receptor Blocker Wins Anoxic Brain Damage of KorEa OHCA Patients

GNT Pharma150 enrolled

Overview

This study aims to investigate the efficacy and safety of Neu2000KWL, a neuroprotectant, in patients resuscitated from out-of-hospital cardiac arrest and receiving therapeutic hypothermia.

Lack of good neurological recovery is the biggest hurdle in the treatment of out-of-hospital cardia arrest. Neu2000KWL, a N-Methyl-D-aspartate (NMDA) receptor antagonist and an antioxidant, attenuated cerebral neuronal death and reduced hypoxic injury of brain in preclinical studies. Phase I clinical study has revealed that Neu2000KWL is very safe for treating human. In current study, the investigators will assess the efficacy of Neu2000KWL to compare the neurological biomarker, brain imaging, and clinical outcomes of patients successfully resuscitated from out-of-cardiac arrest treated by 3-day infusion of Neu2000KWL with patients assigned to placebo arm.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

150

Conditions

Cardiac Arrest

Interventions

Neu2000KWL High-dose groupDRUG

1st infusion of 1500mg in patients within 4 hours following sudden cardiac arrest onset followed by 5 consecutive infusions of 750 mg at intervals of 12 hours(Total drug dosage is 5250mg.)

Neu2000KWL Low-dose groupDRUG

1st infusion of 750mg in patients within 4 hours following sudden cardiac arrest onset followed by 5 consecutive infusions of 500 mg at intervals of 12 hours (Total drug dosage is 3250mg.)

PlaceboDRUG

1st infusion of the same volume of saline in patients within 4 hours following sudden cardiac arrest onset followed by 5 consecutive infusions of the same volume of saline at intervals of 12 hours

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 19 Years to 80 Years (Adult) 2. Out-of-hospital cardiac arrest caused by non-perfusing cardiac rhythm 3. Successful resuscitation accompanied by ROSC time of more than 20 min 4. Therapeutic hypothermia is planned or initiated 5. The first infusion is planned within 4 hours after ROSC 6. Informed consent is obtained from patient or family member(s) 7. No concern with previous cardiovascular surgery Exclusion Criteria: 1. Hypersensitivity to aspirin or sulfasalazine 2. Unwitnessed cardiac arrest 3. CPR time \> 60 min 4. Therapeutic hypothermia is not planned 5. Use of extracorporeal membrane oxygenation (ECMO) at initiation of in-hospital resuscitation (E-CPR) 6. Very poor prognosis is expected: patients with (A) non-cardiac or respiratory arrest, (B) poor basal neurological status (C) secondary cardiac arrest caused by trauma, major bleeding, acute neurologic disease including stroke or tumor, (D) multiorgan failure or advanced malignancy 7. Pregnant or lactating women 8. Participated in other clinical studies within 90 days before randomization; or participating in other clinical trials at present 9. Intracranial bleeding verified by first brain CT imaging 10. The investigators consider the patients are not suitable for this trial

Locations (6)

Kyungpook National University Hospital

Daegu, Korea, South Korea

Soonchunhyang University Bucheon Hospital

Bucheon-si, South Korea

Pusan National University Hospital

Busan, South Korea

Chonnam National University Hospital

Gwangju, South Korea

Outcomes

Primary Outcomes

Verification of difference between of Neuron specific enolase (NSE) value at after 4th infusion of Neu2000KWL.

Blood concentration of neuron specific enolase (NSE)

Time frame: The 3rd day of study (which corresponds to finished 4th infusion of Neu2000KWL).

Secondary Outcomes

Verification of difference between the cumulative of neuron specific enolase (NSE) values at after 6th infusion of Neu2000KWL

Cumulative Blood concentration of neuron specific enolase (NSE)

Time frame: The 4th day of study (which corresponds to finished 6th infusion of Neu2000KWL).

Verification of the difference between groups of Change in NSE values at after the 2nd infusion of Neu2000KWL and after the 6th infusion

The difference of blood neuron specific enolase (NSE) between 24 hour (day 1) and 72 hour (day 3) after the first infusion of Neu2000KWL.

Time frame: At the 24 hours and 72 hours after the first infusion of Neu2000KWL.

Verification of difference between each group of NSE values at after 6th infusion after 1st infusion of Neu2000KWL and 24 hours after end of last infusion

The difference of blood neuron specific enolase (NSE) between day 4 and day 5

Time frame: The 4th and 5th day of study (which corresponds to the timepoint of finished treatment using Neu2000KWL and 24 hour after finished treatment using Neu2000KWL).

Verification of difference between the cerebral infarction at analysis of brain MRI's Apparent Diffusion Coefficient(ADC) images within 48 hours of the last infusion of Neu2000KWL

Blood neuron specific enolase (NSE) at day 5

Time frame: The 5th day of study (which corresponds to 48 hours after finished treatment using Neu2000KWL).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.