- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00628550
Trial of Vasopressin and Epinephrine to Epinephrine Only for In-Hospital Pediatric Cardiopulmonary Resuscitation (Vasopressin)
A Prospective, Randomized, Controlled Trial of Combination Vasopressin and Epinephrine to Epinephrine Only for In-Intensive Care Unit Pediatric Cardiopulmonary Resuscitation
Study Overview
Status
Conditions
Intervention / Treatment
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 trial enrolling 10 patients. This study will be undertaken after consultation with and acceptance by the resuscitation committee and PICU at CMC. 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 either standard dose epinephrine (0.01 mg/kg) or vasopressin (0.8 units/kg) rescue as the second vasopressor medication.
SUMMARY OF STUDY PROCEDURES:
When a patient experiences a CPA, standard Pediatric Advanced Life Saving (PALS) protocols will be followed. This will include: establishment of an airway, support of breathing including supplemental oxygen, evaluation of cardiac rhythm, chest compressions, electrical defibrillation if appropriate, and administration of epinephrine as the first vasopressor medication. The quality of CPR will be monitored and reported by the documenting nurse for the event, to include rate of ventilation, rate and depth of chest compressions, and no-flow time (time without chest compressions). In addition, monitoring of end-tidal CO2, diastolic blood pressure via arterial line if present, and human observation and coaching will be employed to track CPR quality. The patient will then be randomized to receive either epinephrine (control group) or vasopressin (treatment group) as the second vasopressor medication if needed. If further doses of medication are required in either group, epinephrine will be administered according to the PALS algorithm until the end of the CPA event as defined below. Thus, the only difference between the groups will be the replacement of epinephrine with vasopressin as the second vasopressor medication in the algorithm. A total of 120 patients will be enrolled in the randomized, controlled trial portion of the study.
After completion of PICU staff training and prior to the randomized, controlled trial, a pilot trial of vasopressin resuscitation involving 10 patients will be conducted to test the feasibility and safety of study methodology. Pilot participants who meet inclusion criteria will be enrolled serially from the PICU at CMC. Study protocol for the treatment group of the randomized, control trial (vasopressin + epinephrine) will be followed. Collected information will be reviewed by members of a Data Safety and Monitoring Board (DSMB) before proceeding to the next phase of the trial. These patients will not be included in the final analysis.
The requirement of two doses of resuscitation medications will provide adequate time for randomization and use of vasopressin. It will also exclude those children with rapidly reversible conditions who would not have time to benefit from vasopressin versus epinephrine intervention. Stratified randomization technique will be used to control for the effect of vasopressor infusions the patient is receiving at the time of cardiac arrest. Stratification will be based on 4 groups i.e., epinephrine, vasopressin, both, or neither. In order to avoid extreme imbalance in the size of the treatment arms, a permuted block design will be used and the size of each block will be set at 6. SPSS pseudo-random number generator will be used to design the randomization charts. Randomization will be accomplished by the PICU pharmacist via sealed envelopes designating study arm assignment that will be available on every code cart in the PICU. Thus, the study medication will be blinded to all but the pharmacist.
On admission to the PICU, families of all patients will be informed and educated of this ongoing study with exception from informed consent (EFIC) via posters in the waiting rooms and a brochure regarding the study clearly explaining how to "opt out" of inclusion. The number of patients who "opt out" of inclusion will be documented and available to the IRB at their request. Representatives of the study will be available by phone 24 hours a day and in person in the waiting room daily to discuss the study and answer questions. Parents will be informed of inclusion within 24 hours in person or by phone or letter if unavailable. This notification will be documented and consent will be elicited for follow up data collection. CPA events will be limited to those occurring in the PICU only. Providers that respond to CPA events will be in-serviced regarding the study protocol prior to implementation via didactic sessions. Input from pharmacists and providers in the PICU will be sought to assure the easiest implementation possible. Vasopressin is currently available for administration on all resuscitation (code) carts at CMC. Inclusion and exclusion criteria will be posted on all code carts to assist providers. Current protocol at CMC to enter all CPA events into the National Registry of Cardiopulmonary Resuscitation (NRCPR) will be followed. This data is a complete account of the events of the CPA and will be sufficient to meet all of the study's stated goals and objectives. Only data pertinent to the outcomes of this study will be reviewed from the database. This data will also be reviewed to assure standardization of execution of the study protocol.
Time to Completion Given that 89 CPA events met inclusion criteria from January 2005 to June 2006 in the PICU at CMC, approximately 30 months will be required to enroll 130 total patients into this study (10 patients in pilot trial, 120 patients in main study). Subjects will be enrolled in the study until discharge or in-hospital death.
Definition CPA End of Event
- . ROSC that is sustained for > 20mins with no further need for chest compressions, including with a pacemaker or extracorporeal membrane oxygenation OR
- . Resuscitation event is terminated and patient is declared dead (unresponsive to advanced life support, medical futility, advance directive, restriction by family member)
SPECIAL PRECAUTIONS:
A full resuscitation team will be present whenever vasopressin is administered including a physician, nurse, respiratory technician, clinical technician, and pharmacist. A sign will be clearly posted on the bed of any patient whose proxy has "opted" the patient out of the study or who meets any other exclusion criteria. The DSMB will evaluate the study for clear benefit or harm, lack of efficacy, or unacceptable toxicity of vasopressin.
SOURCES OF RESEARCH MATERIALS/ COLLECTION OF FOLLOW UP DATA:
Data from CPA events will be collected from the NRCPR database which is completed at the conclusion of every CPA event currently at CMC. Data is collected in six major categories of variables: (1) Facility data, (2) Patient demographic data, (3) Pre-event data, (4) Event data, (5) Outcome data, and (6) Quality improvement data. All patient identifiers will be destroyed at the earliest possible opportunity. Data will be de-identified for analysis. This data will include laboratory and treatment data from the hospitalization in the PICU at CMC before, during, and after resuscitation. Specifically, this data will include: age, gender, vital signs, treatments, laboratory results, neurologic exam (PCPC and POPC scores) and physical exam. The data collection is based on in-hospital Utstein-style guidelines.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Texas
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Dallas, Texas, United States, 75235
- Universtity of Texas Southwestern, Children's Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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One dose of vasopressin (0.8 units/kg) intravenously rescue as the second vasopressor medication.
Other Names:
|
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.
|
One standard dose epinephrine (0.01 mg/kg) intravenously rescue as the second vasopressor medication.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Immediate
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Combination vasopressin and epinephrine will decrease the time to ROSC
Time Frame: Immediate
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Immediate
|
Vasopressin and epinephrine will improve the proportion of CPA survivors with favorable neurologic outcome (short-term Pediatric Overall Performance Category) [POPC] score discharge of 1-3 or unchanged from hospital admission at the time of hospital .
Time Frame: Period of hospitalization
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Period of hospitalization
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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
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Period of Hospitalization
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Combination vasopressin and epinephrine will improve 24 hour survival.
Time Frame: 24 hrs
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24 hrs
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Combination vasopressin and epinephrine will decrease the proportion of patients who require prolonged CPR (CPR > 20minutes) to achieve sustained ROSC.
Time Frame: Immediate
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Immediate
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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
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Period of hospitalization
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Combination epinephrine and vasopressin will improve rates of return of spontaneous circulation (ROSC)
Time Frame: Immediate
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Immediate
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Tia Tortoriello Raymond, M.D., Universtiy of Texas Southwestern
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Heart Arrest
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Natriuretic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Hemostatics
- Coagulants
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Antidiuretic Agents
- Epinephrine
- Vasopressins
- Arginine Vasopressin
Other Study ID Numbers
- 082007-065
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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