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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.
Register: ClinicalTrials.gov
Last refreshed on: 24 February 2014
Main ID:  NCT01560338
Date of registration: 20/03/2012
Primary sponsor: Children's Hospital of Philadelphia
Public title: Hypothermia's Impact on Pharmacology HIP
Scientific title: Impact of Hypothermia on Midazolam and Morphine Pharmacokinetics
Date of first enrolment: March 2012
Target sample size: 190
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT01560338
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Countries of recruitment
United States
Contacts
Name:   Athena Zuppa, MD MSCE
Address: 
Telephone: 267-426-7359
Email: zuppa@email.chop.edu
Affiliation: 
Name:   Athena F Zuppa, MD MSCE
Address: 
Telephone:
Email:
Affiliation:  Children's Hospital of Philadelphia
Key inclusion & exclusion criteria

Inclusion Criteria:

- Enrolled in Therapeutic Hypothermia After Pediatric Cardiac Arrest (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 Continuous Veno-Venous Hemofiltration
(CVVH), Continuous Veno-Venous Hemodialysis (CVVHD), and Continuous Veno-Venous
Hemodiafiltration (CVVHDF)]



Age minimum: N/A
Age maximum: 17 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Cardiac Arrest
Hypothermia
Intervention(s)
Primary Outcome(s)
Physiologic manifestations of cardiac arrest and Multiple Organ Dysfunction Syndrome (MODS) in relation to morphine and midazolam [Time Frame: 2.5 years]
Secondary Outcome(s)
Impact of genetic factors [Time Frame: 2.5 years]
Secondary ID(s)
12-009214
RO1HL11274501A1
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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