Status:
COMPLETED
Trial of Vasopressin and Epinephrine to Epinephrine Only for In-Hospital Pediatric Cardiopulmonary Resuscitation
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Children's Medical Center Dallas
Conditions:
Cardiopulmonary Arrest
Cardiac Arrest
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE1
Brief 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 resu...
Detailed Description
CONCISE SUMMARY OF PROJECT: The study design will be a prospective, randomized, controlled clinical trial to be conducted in the PICU of CMC Dallas (UT Southwestern Medical Center) following a pilot ...
Eligibility Criteria
Inclusion
- All children, ages 0 to 18 years, admitted to the PICU who experience CPA requiring either chest compressions and/or defibrillation. This will include males, females and Spanish speaking individuals.
- Patients must require at least 2 doses of vasopressor medication during the CPA event (all patients would receive epinephrine as first dose, followed by either epinephrine or vasopressin as second dose depending on randomization, all subsequent doses required would be epinephrine) given via any route (intravenous, intraosseous, or endotracheal).
Exclusion
- Do Not Attempt Resuscitate (DNAR) patients
- Chemical code only (i.e., no CPR/defibrillation)
- Events not requiring chest compressions and/or defibrillation
- Events with a pulse requiring synchronized or unsynchronized cardioversion
- Successful internal cardiac device defibrillation of Vfib/pVT that initiates the resuscitation event
- Defibrillation for Vfib/pVT without administration of a vasopressor
- All patients in the custody of the State of Texas
- Any patient whose parent or guardian "opts out" of the study
- Any patient who is pregnant
- Any patient whose attending physician "opts out" of the study
- Any patient who does not consent to follow up data collection
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00628550
Start Date
April 1 2008
End Date
October 1 2010
Last Update
September 17 2019
Active Locations (1)
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1
Universtity of Texas Southwestern, Children's Medical Center
Dallas, Texas, United States, 75235