World Health Organization site
Skip Navigation Links

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.
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
Study type:  Observational
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Countries of recruitment
United States
Name:   Athena Zuppa, MD MSCE
Telephone: 267-426-7359
Name:   Athena F Zuppa, MD MSCE
Affiliation:  Children's Hospital of Philadelphia
Key inclusion & exclusion criteria

Inclusion Criteria:

- Enrolled in Therapeutic Hypothermia After Pediatric Cardiac Arrest (THAPCA) Clinical

- 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
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)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.1 - Version history