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Vasoconstrictor

Vasopressin vs. Epinephrine for Neonatal Cardiac Arrest

Phase 1

Recruiting

Led By Georg Schmolzer

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Infants (term or preterm infants) born without heart beat or with bradycardia

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24-28 hours after birth

Awards & highlights

Study Summary

This trial will compare epinephrine and vasopressin during CPR to see which is more effective in newborn babies when they are born with a low heart rate or no heart rate.

Who is the study for?

This trial is for newborn babies, both full-term and preterm, who are born with a very low heart rate or no heart rate at all. Babies with congenital heart defects like hypo-plastic left heart or conditions that affect breathing such as congenital diaphragmatic hernia cannot participate.Check my eligibility

What is being tested?

The study compares two medications used during CPR in newborns: vasopressin and epinephrine. Hospitals will use one of these drugs for a year when performing CPR on babies with low or no heartbeat at birth. The goal is to see if vasopressin offers more benefits than the commonly used epinephrine.See study design

What are the potential side effects?

Potential side effects from either medication can include changes in blood pressure, abnormal heart rhythm, and possibly reduced blood flow to certain organs due to their effects on the cardiovascular system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My baby was born without a heartbeat or with a very slow heart rate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24-28 hours after birth

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24-28 hours after birth

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-28 hours after birth for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to ROSC (Return of spontaneous Circulation)

Secondary outcome measures

Acute Kidney injury

Admission temperature

Blood gases and serum sodium levels

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: VasopressinExperimental Treatment1 Intervention

"Vasopressin group" Vasopressin will be via umbilical vein catheter (0.4 IU/kg per dose - first line) or alternatively via an endotracheal tube (8 IU/kg) every three to five minutes as needed with a maximum of two doses if there is no ROSC [2,3] After that, the clinical team must convert to give epinephrine (0.02 mg/kg per dose) as long as CPR is ongoing.

Group II: EpinephrineActive Control1 Intervention

Epinephrine group" Epinephrine will be administered according to current resuscitation guidelines either via umbilical vein catheter (0.02 mg/kg per dose) or via endotracheal tube (0.1 mg/kg) every three to five minutes as needed[2,3]. Chest compressions and epinephrine will be continued until ROSC.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vasopressin

2014

Completed Phase 4

~24780

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

385,157 Total Patients Enrolled

Georg SchmolzerPrincipal InvestigatorUniversity of Alberta

5 Previous Clinical Trials

69 Total Patients Enrolled

Media Library

Epinephrine (Vasoconstrictor) Clinical Trial Eligibility Overview. Trial Name: NCT05738148 — Phase 1

Cardiac Arrest Research Study Groups: Epinephrine, Vasopressin

Cardiac Arrest Clinical Trial 2023: Epinephrine Highlights & Side Effects. Trial Name: NCT05738148 — Phase 1

Epinephrine (Vasoconstrictor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05738148 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment include participants who are older than 25?

"This medical trial allows participants of all ages, starting from 0 minutes old up to 20 minutes."

Answered by AI

What potential risks can be associated with the use of Vasopressin?

"The team at Power judged Vasopressin to be of relative low safety due to the lack of clinical data in Phase 1 trials."

Answered by AI

Does this research study have any spots left for participants?

"Confirmed, the research study detailed on clinicaltrials.gov is not presently recruiting participants. It was initially launched in September of 2023 and most recently updated on February 20th 2023; however, there are still 64 other active trials that have open enrollment slots for willing patients."

Answered by AI

Could I be admitted to this research project?

"The current medical study is looking for 20 neonatal patients between 0 and 20 minutes old that have experienced cardiac arrest. Furthermore, those wishing to enrol must satisfy the inclusion criteria of being either a term or preterm infant who was born without a heartbeat or bradycardic."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vasopressin vs. Epinephrine During Neonatal Cardiopulmonary Resuscitation

2023. "Vasopressin vs. Epinephrine During Neonatal Cardiopulmonary Resuscitation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05738148.

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