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| Sponsor: | University of Texas Southwestern Medical Center |
|---|---|
| Collaborator: |
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-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 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. Prior to commencement of the RCT, a pilot trial of 10 patients will be completed to assess preliminary safety, feasibility, and effectiveness of combination epinephrine-vasopressin for pediatric in-intensive care unit CPA refractory to initial epinephrine dosing. All pilot patients will receive vasopressin as the second vasopressor medication.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiopulmonary Arrest Cardiac Arrest |
Drug: Vasopressin Drug: Epinephrine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Randomized, Controlled Trial of Combination Vasopressin and Epinephrine to Epinephrine Only for In-Intensive Care Unit 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 |
|---|---|
|
Experimental: 1
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.
Other Name: Pitressin
|
|
Active Comparator: 2
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.
Other Name: Adrenaline
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Tia Tortoriello Raymond, M.D. | 9725337175 | Tiaraymond@me.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 | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Tia Tortoriello Raymond, M.D. 214-456-2281 Tia.Tortoriello@Childrens.com | |
| Principal Investigator: Tia Tortoriello Raymond, M.D. | |
| Sub-Investigator: Timothy G Carroll, M.D. | |
| Sub-Investigator: Vivian Dimas, M.D. | |
| Sub-Investigator: Daniel Stromberg, M.D. | |
| Sub-Investigator: Craig Huang, M.D. | |
| Principal Investigator: | Tia Tortoriello Raymond, M.D. | Universtiy of Texas Southwestern |
More Information
| Responsible Party: | Tia Tortoriello Raymond, MD, Medical City Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT00628550 History of Changes |
| Other Study ID Numbers: | 082007-065 |
| Study First Received: | February 24, 2008 |
| Last Updated: | June 24, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
cardiac arrest cardiopulmonary arrest vasopressin |
epinephrine pediatrics in hospital cardiopulmonary resuscitation |
|
Heart Arrest Heart Diseases Cardiovascular Diseases Epinephrine Vasopressins Arginine Vasopressin Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents |
Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Mydriatics Adrenergic alpha-Agonists Sympathomimetics Vasoconstrictor Agents Cardiovascular Agents Hemostatics Coagulants Hematologic Agents Antidiuretic Agents Natriuretic Agents |