Hypothermia's Impact on Pharmacology

NCT01560338 | Completed

• 2 other identifiers: 12-009214RO1HL11274501A1
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Cardiac Arrest; Hypothermia

Keywords

Pharmacokinetics; Midazolam; Morphine; Cardiac Arrest; Hypothermia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Impact of genetic factors

  2.5 years

Other Outcomes (1)

• Manifestations of hypothermia

  2.5 years

Study Arms (1)

Pediatric after Cardiac Arrest

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.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Be greater than or equal to three (3) kg
• Receiving or have received morphine and/or midazolam as part of clinical care
• Receiving hypothermia after any cardiac arrest
• Provide Informed Consent

You may not qualify if:

• Receiving renal replacement therapy \[example Continuous Veno-Venous Hemofiltration (CVVH), Continuous Veno-Venous Hemodialysis (CVVHD), and Continuous Veno-Venous Hemodiafiltration (CVVHDF)\]
• Receiving plasmapheresis

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (9)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Univeristy of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Nationwide Children's Medical Center

Columbus, Ohio, 43205, United States

Location

Pennsylvania State University Hersey Medical Center

Hershey, Pennsylvania, 19104, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Heart Arrest; Hypothermia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Athena F Zuppa, MD MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 22, 2012
• Study Start: March 1, 2012
• Primary Completion: January 1, 2018
• Study Completion: January 28, 2018
• Last Updated: March 2, 2021

Record last verified: 2021-03

Locations

US (9)