Trial of Terbutaline for the Treatment of Status Asthmaticus in Children - Tabular View

Tracking Information

First Received Date ^ICMJE

July 27, 2005

Last Updated Date

September 7, 2006

Start Date ^ICMJE

October 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

ICU length of stay

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00124995 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the effects of intravenous terbutaline on pulmonary mechanics over length of ICU admission
To prospectively analyze the side effects of terbutaline

Original Secondary Outcome Measures ^ICMJE

- To evaluate the effects of intravenous terbutaline on pulmonary mechanics over length of ICU admission
- To prospectively analyze the side effects of terbutaline

Descriptive Information

Brief Title ^ICMJE

Trial of Terbutaline for the Treatment of Status Asthmaticus in Children

Official Title ^ICMJE

Double-Blinded Randomized Trial of Terbutaline to Shorten ICU Length of Stay in the Treatment of Status Asthmaticus in Children

Brief 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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Status Asthmaticus

Intervention ^ICMJE

Drug: terbutaline

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

up to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00124995

Responsible Party

Study ID Numbers ^ICMJE

05-001

Study Sponsor ^ICMJE

Connecticut Children's Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Christopher Carroll, MD

CT Children's Medical Center

Information Provided By

Connecticut Children's Medical Center

Verification Date

September 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP