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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
Must not have
Congenital heart disease (e.g., hypo-plastic left heart)
Condition that have adverse effect on breathing or ventilation (e.g., congenital diaphragmatic hernia)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-28 hours after birth
Awards & highlights

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I was born with a heart condition.
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I have a condition that makes it hard for me to breathe.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to ROSC (Return of spontaneous Circulation)
Secondary study objectives
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

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
913 Previous Clinical Trials
390,413 Total Patients Enrolled
2 Trials studying Cardiac Arrest
1,192 Patients Enrolled for Cardiac Arrest
Georg SchmolzerPrincipal InvestigatorUniversity of Alberta
5 Previous Clinical Trials
71 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
~12 spots leftby Nov 2025
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