Trial of Terbutaline for the Treatment of Status Asthmaticus in Children
Information source: Connecticut Children's Medical Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Status Asthmaticus
Intervention: terbutaline (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Connecticut Children's Medical Center Official(s) and/or principal investigator(s):
Christopher Carroll, MD, Principal Investigator, Affiliation: CT Children's Medical Center
Summary
Although widely used for the treatment of pediatric status asthmaticus, intravenous
terbutaline has potentially significant side effects; may not improve outcomes; and may
increase Intensive Care Unit (ICU) length of stay. This study is designed to test the
efficacy of intravenous terbutaline for the treatment of status asthmaticus by adding
intravenous terbutaline or placebo to standard asthma treatment. The dose of terbutaline or
placebo will be titrated according to severity of illness as quantified by a validated
clinical asthma score. Differences in outcomes between the study groups, such as length of
stay, hospital costs, and lung function will be compared.
Clinical Details
Official title: Double-Blinded Randomized Trial of Terbutaline to Shorten ICU Length of Stay in the Treatment of Status Asthmaticus in Children
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Primary outcome: ICU length of stay
Secondary outcome: To evaluate the effects of intravenous terbutaline on pulmonary mechanics over length of ICU admissionTo prospectively analyze the side effects of terbutaline
Eligibility
Minimum age: N/A.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Admission to the Connecticut Children's Medical Center (CCMC) Pediatric Intensive Care
Unit (PICU) with a primary admission diagnosis of status asthmaticus
- Modified Pulmonary Index Score (MPIS) of greater than or equal to 12
- Age between birth and 18 years old
Exclusion Criteria:
- Pre-existing cardiac or pulmonary disease
- Existing respiratory failure (requiring invasive or non-invasive mechanical
ventilation)
- Hemodynamic or cardiovascular instability requiring inotropic support
- The patient meets one of the criteria for withdrawal from the study due to patient
safety concerns
Locations and Contacts
CT Children's Medical Center, Hartford, Connecticut 06106, United States
Additional Information
Starting date: October 2003
Last updated: September 7, 2006
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