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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 February 2013 |
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Main ID: |
NCT01560338 |
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Date of registration:
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20/03/2012 |
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Primary sponsor: |
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Public title:
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Hypothermia's Impact on Pharmacology
HIP |
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Scientific title:
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Impact of Hypothermia on Midazolam and Morphine Pharmacokinetics |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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190 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01560338 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Athena Zuppa, MD MSCE |
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Address:
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Telephone:
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267-426-7359 |
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Email:
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zuppa@email.chop.edu |
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Affiliation:
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Name:
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Athena F Zuppa, MD MSCE |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital of Philadelphia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Enrolled in THAPCA Clinical Trial
- Be greater than or equal to five kg
- Receiving or have received morphine and/or midazolam as part of clinical care
- Provide Informed consent
Exclusion Criteria:
- Receiving therapy with extracorporeal membrane oxygenation (ECMO)
- Receiving renal replacement therapy (example CVVH, CVVHD, CVVHDF)
Age minimum:
N/A
Age maximum:
17 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cardiac Arrest
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Hypothermia
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Primary Outcome(s)
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Physiologic manifestations of cardiac arrest and Multiple Organ Dysfunction Syndrome (MODS) in relation to morphine and midazolam
[Time Frame: 2.5 years]
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Secondary Outcome(s)
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Impact of genetic factors
[Time Frame: 2.5 years]
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Secondary ID(s)
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12-009214
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RO1HL11274501A1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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