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NCT00628550 · ClinicalTrials.gov registry record · Phase 1
Trial of Vasopressin and Epinephrine to Epinephrine Only for In-Hospital Pediatric Cardiopulmonary Resuscitation
A Phase 1 study of Cardiac Arrest and Cardiopulmonary Arrest, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 130
- Enrollment target
- 1
- Study location
NCT00628550 is a Phase 1 study of Cardiac Arrest and Cardiopulmonary Arrest that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 130 participants, below the 1,476-participant average among 31 other Cardiac Arrest trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00628550, a Phase 1 study of Cardiac Arrest and Cardiopulmonary Arrest, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 130 participants
- Enrollment target
- 1
- Study location
Study Summary
Cardiac arrest has a very poor prognosis, especially with prolonged efforts at resuscitation, and unfortunately, survivors are often severely neurologically impaired. CPA in children is often the result of a prolonged illness rather than a sudden, primary cardiac event as is frequent in adults. This necessitates that resuscitation research must be conducted separately for pediatric and adult patients. Authorities currently endorse the use of epinephrine for restoring spontaneous circulation based on its ability to maintain diastolic blood pressure and subsequent blood flow to the heart during resuscitation. However, human studies have shown no clear survival benefit of epinephrine and have elucidated concerning adverse effects. Recently, both the European Resuscitation Council and the American Heart Association have recognized the use of vasopressin as a promising vasoconstrictor and an alternative or adjunct to epinephrine in the resuscitation of adults. Vasopressin causes profound vasoconstriction without the adverse effects of epinephrine and is associated with improved blood flow to the heart and brain. This increased cerebral blood flow has been associated with better neurologic outcome in animal studies. In light of compelling animal and human studies of combined vasopressin and epinephrine, pediatric trials are indicated for vasopressin usage in pediatric CPR. This study will evaluate the addition of the administration of vasopressin to standard advanced CPR therapy (epinephrine alone) for pediatric patients that experience in-intensive care unit CPA to assess for improved time to return of spontaneous circulation (ROSC), survival to 24 hours, survival to hospital discharge, and neurologic outcome. When a patient experiences a CPA, standard Pediatric Advanced Life Saving (PALS) protocols as endorsed by the American Heart Association will be initiated. This will include receiving epinephrine as the first vasopressor medication. Patients will then be randomized
Conditions Studied
Interventions
- DRUG Epinephrine
- DRUG Vasopressin
Study Locations (1)
Texas
- Universtity of Texas Southwestern, Children's Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2008-04 |
| Est. Completion | 2010-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00628550
The ClinicalTrials.gov registry entry for NCT00628550 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,476-participant average among 31 other Cardiac Arrest trials with a reported enrollment target (91% lower). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cardiac Arrest appearing as the primary indexed condition, and to 2 interventions - of which Epinephrine is the first listed.
NCT00628550 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT00628550 about?
NCT00628550 is a clinical study titled "Trial of Vasopressin and Epinephrine to Epinephrine Only for In-Hospital Pediatric Cardiopulmonary Resuscitation". Cardiac arrest has a very poor prognosis, especially with prolonged efforts at resuscitation, and unfortunately, survivors are often severely neurologically impaired. CPA in children is often the result of a prolonged illness rather than a sudden, primary cardiac event as is frequent in adults. This...
What is the current status of trial NCT00628550?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 130 participants. The study started on 2008-04. Estimated completion is 2010-10.
What conditions does trial NCT00628550 study?
This clinical trial studies the following conditions: Cardiac Arrest, Cardiopulmonary Arrest.
What interventions are being tested in trial NCT00628550?
The interventions under investigation include: Epinephrine (DRUG), Vasopressin (DRUG).
Who is sponsoring clinical trial NCT00628550?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00628550 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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