NCT03191240

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2017

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 19, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

December 31, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

March 8, 2022

Status Verified

February 1, 2022

Enrollment Period

3.7 years

First QC Date

June 13, 2017

Last Update Submit

February 21, 2022

Conditions

Out-of-Hospital Cardiac Arrest

Keywords

Out-of-Hospital Cardiac ArrestVasopressin

Outcome Measures

Primary Outcomes (1)

  • Sustained return of spontaneous circulation (ROSC)

    CPCR result Achievement of sustained ROSC was declared when patients had a palpable pulse for more than 20 minutes.

    for 20 minutes after the time that participants had a palpable pulse

Secondary Outcomes (6)

  • Improvement of arterial diastolic blood pressure assessed by arterial line

    during CPR, every 10 seconds after arterial line insertion until the termination of CPR due to ROSC or death, whichever came first, assessed up to 30 minutes

  • Improvement of end-tidal carbon dioxide concentrations assessed by capnography

    during CPR, every one minute after endotracheal tube insertion until the termination of CPR due to ROSC or death, whichever came first, assessed up to 30 minutes

  • Improvement of acid-base status measured by blood-gas analysis

    during CPR, 5, 10, 15, and 20 minute after arterial line insertion and termination of CPR

  • Improvement of lactate level measured by blood-gas analysis

    during CPR, 5, 10, 15, and 20 minute after arterial line insertion and termination of CPR

  • Low level of neuron specific enolase level

    24, 48, and 72 hours after ROSC

  • +1 more secondary outcomes

Study Arms (2)

Vasopressins

EXPERIMENTAL

Additional vasopressin 40 IU intravenous injection for 2 times

Drug: Vasopressins

Normal saline

PLACEBO COMPARATOR

Additional normal saline intravenous injection for 2 times

Drug: Normal saline

Interventions

VasopressinsDRUG

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

Also known as: Vasopressin inj
Vasopressins
Normal salineDRUG

Placebo

Also known as: 0.9% sodium chloride
Normal saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chonnam National University Hospital

Gwangju, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (1)

  • Oh DK, Kim JS, Ryoo SM, Kim YJ, Kim SM, Hong SI, Chae B, Kim WY. Augmented-Medication CardioPulmonary Resuscitation (AMCPR) trial: a study protocol for a randomized controlled trial. Clin Exp Emerg Med. 2022 Dec;9(4):361-366. doi: 10.15441/ceem.22.367. Epub 2022 Nov 2.

    PMID: 36318879DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestDiabetes Insipidus

Interventions

VasopressinsSaline SolutionSodium Chloride

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Won Young Kim, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 19, 2017

Study Start

December 31, 2017

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

March 8, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)