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Sponsors and Collaborators: |
University of Texas Southwestern Medical Center Children's Medical Center Dallas |
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Information provided by: | University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00628550 |
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 |
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Cardiopulmonary Arrest Cardiac Arrest |
Drug: Vasopressin Drug: Epinephrine |
Phase I |
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 |
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 |
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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.
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Drug: Vasopressin
One dose of vasopressin (0.8 units/kg) intravenously rescue as the second vasopressor medication.
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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.
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Drug: Epinephrine
One standard dose epinephrine (0.01 mg/kg) intravenously rescue as the second vasopressor medication.
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Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
United States, Texas | |
Universtity of Texas Southwestern, Children's Medical Center | |
Dallas, Texas, United States, 75235 |
Principal Investigator: | Tia Tortoriello Raymond, M.D. | Universtiy of Texas Southwestern |
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 History of Changes |
Health Authority: | United States: Food and Drug Administration |
cardiac arrest cardiopulmonary arrest vasopressin |
epinephrine pediatrics in hospital cardiopulmonary resuscitation |
Neurotransmitter Agents Heart Diseases Adrenergic alpha-Agonists Adrenergic beta-Agonists Adrenergic Agents Anti-Asthmatic Agents Heart Arrest Cardiovascular Agents Hemostatics |
Adrenergic Agonists Arginine Vasopressin Mydriatics Vasopressins Vasoconstrictor Agents Peripheral Nervous System Agents Epinephrine Bronchodilator Agents |
Respiratory System Agents Neurotransmitter Agents Coagulants Adrenergic Agents Molecular Mechanisms of Pharmacological Action Hematologic Agents Physiological Effects of Drugs Adrenergic Agonists Arginine Vasopressin Therapeutic Uses Vasoconstrictor Agents Vasopressins Cardiovascular Diseases Epinephrine Heart Diseases |
Adrenergic alpha-Agonists Adrenergic beta-Agonists Sympathomimetics Anti-Asthmatic Agents Heart Arrest Cardiovascular Agents Pharmacologic Actions Hemostatics Mydriatics Natriuretic Agents Autonomic Agents Peripheral Nervous System Agents Antidiuretic Agents Bronchodilator Agents |