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Trial of Vasopressin and Epinephrine to Epinephrine Only for In-Hospital Pediatric Cardiopulmonary Resuscitation
This study is not yet open for participant recruitment.
Verified by University of Texas Southwestern Medical Center, February 2008
Sponsors and Collaborators: University of Texas Southwestern Medical Center
Children's Medical Center Dallas
Information provided by: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00628550
  Purpose

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-hospital 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 to receive vasopressin (treatment group) or epinephrine (control group) as the second vasopressor medication, if needed. If more then two doses of vasopressor medication is required in either group, epinephrine will be administered according to the PALS algorithm until the end of the event. All CPA events meeting inclusion criteria will be entered into the National Registry of Cardiopulmonary Resuscitation (NRCPR) Database, which tracts all CPA events at Children's Medical Center Dallas.


Condition Intervention Phase
Cardiopulmonary Arrest
Cardiac Arrest
Drug: Vasopressin
Drug: Epinephrine
Phase I

MedlinePlus related topics: CPR
Drug Information available for: Epinephrine Epinephrine bitartrate Argipressin Vasopressins
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: A Prospective, Randomized, Controlled Trial of Combination Vasopressin and Epinephrine to Epinephrine Only for In-Hospital Pediatric Cardiopulmonary Resuscitation

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Combination vasopressin and epinephrine (CPA refractory to cardiopulmonary resuscitation and initial epinephrine dosing) will increase the proportion of patients surviving to hospital discharge by 25% compared to epinephrine alone. [ Time Frame: Immediate ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Combination vasopressin and epinephrine will decrease the time to ROSC [ Time Frame: Immediate ] [ Designated as safety issue: No ]
  • Vasopressin and epinephrine will improve the proportion of CPA survivors with favorable neurologic outcome (short-term Pediatric Overall Performance Category) [POPC] scordischargee of 1-3 or unchanged from hospital admission at the time of hospital . [ Time Frame: Period of hospitalization ] [ Designated as safety issue: No ]
  • Vasopressin and epinephrine will improve the proportion of CPA survivors with favorable neurologic outcome (short-term Pediatric Cerebral Performance Category) [PCPC] score of 1-3 or unchanged from hospital admission at time of hospital discharge. [ Time Frame: Period of Hospitalization ] [ Designated as safety issue: No ]
  • Combination vasopressin and epinephrine will improve 24 hour survival. [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • Combination vasopressin and epinephrine will decrease the proportion of patients who require prolonged CPR (CPR > 20minutes) to achieve sustained ROSC. [ Time Frame: Immediate ] [ Designated as safety issue: No ]
  • Combination vasopressin and epinephrine will increase organ recovery in those patients who meet brain death criteria following the CPA event. [ Time Frame: Period of hospitalization ] [ Designated as safety issue: No ]
  • Combination epinephrine and vasopressin will improve rates of return of spontaneous circulation (ROSC) [ Time Frame: Immediate ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: April 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Pediatric patients that experience in-hospital CPA who remain in cardiac arrest despite CPR and an initial, standard dose of epinephrine (0.01 mg/kg), will be randomly assigned to receive vasopressin (0.8 units/kg) rescue as the second vasopressor medication.
Drug: Vasopressin
One dose of vasopressin (0.8 units/kg) intravenously rescue as the second vasopressor medication.
2: Active Comparator
Pediatric patients that experience in-hospital CPA who remain in cardiac arrest despite CPR and an initial, standard dose of epinephrine (0.01 mg/kg), will be randomly assigned to receive standard dose epinephrine (0.01 mg/kg)rescue as the second vasopressor medication.
Drug: Epinephrine
One standard dose epinephrine (0.01 mg/kg) intravenously rescue as the second vasopressor medication.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00628550

Contacts
Contact: Tia Tortoriello Raymond, M.D. 214-456-2281 Tia.Tortoriello@Childrens.com
Contact: Timothy G Carroll, M.D. 214-456-7614 Timothy.Carroll@Childrens.com

Locations
United States, Texas
Universtity of Texas Southwestern, Children's Medical Center
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Children's Medical Center Dallas
Investigators
Principal Investigator: Tia Tortoriello Raymond, M.D. Universtiy of Texas Southwestern
  More Information

Responsible Party: University of Texas Southwestern Medical Center ( Tia Tortoriello Raymond, MD )
Study ID Numbers: 082007-065
Study First Received: February 24, 2008
Last Updated: March 4, 2008
ClinicalTrials.gov Identifier: NCT00628550  
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:
cardiac arrest
cardiopulmonary arrest
vasopressin
epinephrine
pediatrics
in hospital cardiopulmonary resuscitation

Study placed in the following topic categories:
Arginine Vasopressin
Heart Diseases
Vasopressins
Heart Arrest
Epinephrine

Additional relevant MeSH terms:
Respiratory System Agents
Neurotransmitter Agents
Adrenergic alpha-Agonists
Coagulants
Adrenergic beta-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Sympathomimetics
Hematologic Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cardiovascular Agents
Hemostatics
Pharmacologic Actions
Adrenergic Agonists
Mydriatics
Natriuretic Agents
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Diseases
Peripheral Nervous System Agents
Antidiuretic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009