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Pharmacologic Impact on Sedation Assessments

NCT01105663 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 175

Last updated 2017-01-27

No results posted yet for this study

Summary

PISA is an ancillary study to the NIH funded clinical RESTORE Trial (U01 HL086622). This study will provide data that may allow for improved dosing recommendations in this critically ill population of children.

Conditions

  • Pediatric Acute Lung Injury

Interventions

OTHER

Pharmacokinetic Sampling and pharmacogenetic analysis

Pharmacogenetic and pharmacokinetic samples will be obtained from a peripheral catheter, central catheter, or venipuncture coordinated with scheduled phlebotomies. Pharmacokinetic and pharmacogenetic analyses will be performed. Pharmacodynamic data will be collected.

Sponsors & Collaborators

Principal Investigators

  • Athena Zuppa, MD MSCE · Children's Hospital of Philadelphia

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01105663 on ClinicalTrials.gov