NCT01560338|Completed
Hypothermia's Impact on Pharmacology
HIP
Impact of Hypothermia on Midazolam and Morphine Pharmacokinetics
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HIP
Impact of Hypothermia on Midazolam and Morphine Pharmacokinetics
Sponsor study identifier
Secondary identifiers
OTHER · NIHLBI
observational
41
1 country
9
Study Start
March 2012
Actual (reported)Primary Completion
January 2018
Actual (reported)Study Completion
January 28, 2018
Actual (reported)The purpose of the study will help us understand the complex interaction between hypothermia (cooling) and pharmacogenetics (how specific genes effect how drugs are handled), and their impact on how routinely given sedation drug are broken down and used by the body when given to children after cardiac arrest (when heart stops pumping blood) and are critically ill.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 28, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2012
Actual (reported)March 20, 2012
Actual (reported)March 22, 2012
Actual (reported)January 2018
Actual (reported)January 28, 2018
Actual (reported)Physiologic manifestations of cardiac arrest and Multiple Organ Dysfunction Syndrome (MODS) in relation to morphine and midazolam
The objective of this aim is to identify the physiologic manifestations of cardiac arrest and MODS that underlie the variability in morphine and midazolam pharmacokinetics.
2.5 years
Impact of genetic factors
2.5 years
Manifestations of hypothermia
2.5 years
Pediatric patients greater than 3 kg. and less than 18 years suffering cardiac arrest who have been given or currently receiving morphine and/or midazolam and receiving hypothermia.
The study population is the pediatric population equal to or greater than 3 kg and less than 18 years of age AND have had or currently receiving morphine and/or midazolam AND receive hypothermia after cardiac arrest administered as part of clinical care.
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Univeristy of Michigan
Ann Arbor, Michigan, 48109, United States
Nationwide Children's Medical Center
Columbus, Ohio, 43205, United States
Pennsylvania State University Hersey Medical Center
Hershey, Pennsylvania, 19104, United States
The Children's Hospital of Philadelphia
Whole blood
Athena F Zuppa, MD MSCE
Children's Hospital of Philadelphia
41 participants (actual enrollment reported by the registry).
First Submitted
March 20, 2012
First Posted
March 22, 2012
Study Start
March 2012
Actual (reported)COOL-Trial: Outcome With Invasive and Non-invasive Cooling After Cardiac Arrest
Contact the study team to confirm eligibility.
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Primary Completion
January 2018
Actual (reported)Study Completion
January 28, 2018
Actual (reported)Last Updated
March 2, 2021
Record last verified: 2021-03
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Source: ClinicalTrials.gov.
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