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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-29

Study Completion Date

2021-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Double Blind (Subject, Caregiver, Investigator)

Study Groups

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Neu2000KWL high dose

Group Type EXPERIMENTAL

Neu2000KWL High-dose group

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Neu2000KWL Low-dose group

Intervention Type DRUG

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.)

saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Neu2000KWL High-dose group

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.)

Intervention Type DRUG

Neu2000KWL Low-dose group

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.)

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No