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...
Date First Received: July 27, 2005
Last Updated: September 7, 2006
Verified by: Connecticut Children's Medical Center, September 2006
Clinical Trial Phase: Phase 4 | Start Date: October 2003
Overall Status: Completed
Estimated Enrollment: 40
Brief Summary
Official Title: “Double-Blinded Randomized Trial of Terbutaline to Shorten ICU Length of Stay in the Treatment of Status Asthmaticus in Children”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: terbutaline
Outcome Measures for this Clinical Trial
Primary Measures
- ICU length of stay
Secondary Measures
- To evaluate the effects of intravenous terbutaline on pulmonary mechanics over length of ICU admission
- To prospectively analyze the side effects of terbutaline
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: 18 Years
Clinical Trial Sponsor Information
Lead Sponsor: Connecticut Children's Medical Center
Overall Clinical Trial Officials and Contacts
Christopher Carroll, MD Principal Investigator CT Children's Medical Center
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00124995
Study ID Number: 05-001
ClinicalTrials.gov Identifier: NCT00124995
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
