AMCPR (Augmented-Medication CardioPulmonary Resuscitation) Trial for OHCA

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-31

Study Completion Date

2021-08-31

Brief Summary

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The investigators aimed to evaluate the effect of AMCPR (Augmented-Medication CardioPulmonary Resuscitation: administration of additional vasopressin to titrate to arterial diastolic blood pressure over 20 mmHg) on cardiopulmonary resuscitation results and outcomes in out-of-hospital cardiac arrest patients.

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Detailed Description

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Non-traumatic out-of-hospital cardiac arrest patients receive standard advanced cardiac life support according to the 2015 AHA guideline, including chest compression, intubation, ventilation, defibrillation, drug administration, including epinephrine and antiarrhythmic drugs if indicated, in the emergency department.

A research associate generates a random sequence using Excel software, and assignment of participants to their respective groups will be undertaken by the principal investigator.

Arterial line insertion is performed within 6 minutes after randomization and diastolic blood pressure will be monitored.

If diastolic blood pressure is \< 20 mmHg, drugs (vasopressin 40 IU or normal saline) will be administered for two times during CPR.

Arterial blood gas analysis will be analyzed for 5, 10, 15, and 20 minutes after arterial line insertion or termination of CPR.

End-tidal carbon dioxide concentrations is monitored in real time during CPR and recorded every minute.

The resuscitated patients receive standard post cardiac arrest care according to the 2015 AHA guideline.

Conditions

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Out-of-Hospital Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Vasopressins

Additional vasopressin 40 IU intravenous injection for 2 times

Group Type EXPERIMENTAL

Vasopressins

Intervention Type DRUG

Administer additional vasopressin 40 IU IV for 2 times during cardiopulmonary resuscitation

Normal saline

Additional normal saline intravenous injection for 2 times

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Placebo

Interventions

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Vasopressins

Administer additional vasopressin 40 IU IV for 2 times during cardiopulmonary resuscitation

Intervention Type DRUG

Normal saline

Placebo

Intervention Type DRUG

Other Intervention Names

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Vasopressin inj 0.9% sodium chloride

Eligibility Criteria

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Inclusion Criteria

* non-traumatic adult out-of-hospital cardiac arrest (OHCA) patients with non-shockable arrest rhythm

Exclusion Criteria

* OHCA with terminal illness documented by medical record, under hospice care, with pregnancy, with pre-documented 'Do Not Resuscitate' card
* trauma patients
* age \< 18 years old
* failed arterial line insertion within 6 minutes after randomization
* Extracorporeal cardiopulmonary resuscitation
* Time interval between arrest and ED arrival \> 60 minutes
* ROSC within 6 minutes after ED arrival
* Diastolic Blood Pressure \> 20 mmHg during resuscitation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No