Intravenous Terbutaline in Severe Status Asthmaticus - Full Text View

Purpose

Terbutaline is a medication that is used to treat serious asthma attacks (status asthmaticus). The purpose of this study is to determine if terbutaline is effective and safe when given as a continuous intravenous infusion to children ages 2 years to 18 years of age. Children participating in this study are inpatients in the Intensive Care Unit with a diagnosis of status asthmaticus and are receiving terbutaline as part of their routine care. Blood samples and physiological assessments will be used to determine how the body is using terbutaline and how well it is working.

Condition

Status Asthmaticus

MedlinePlus related topics:

Asthma

ChemIDplus related topics:

Terbutaline Terbutaline sulfate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	Pharmacokinetics and Pharmacodynamics of Terbutaline Given as a Continuous Intravenous Infusion in Severe Status Asthmaticus

Further study details as provided by Wayne State University:

Primary Outcome Measures:

Pharmacokinetics of continuous terbutaline infusion [ Time Frame: Prior to infusion; 20 minutes, 2, 4, 6, 8, 10, 12 hours post infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Modified Pulmonary Index Score (MPIS) [ Time Frame: Assess every 4 hours while IV terbutaline is infusing, continuing for 8 hours after the infusion is discontinued ] [ Designated as safety issue: No ]
Physiologic parameters [ Time Frame: Prior to terbutaline, 20 minutes post, then hourly during infusion ] [ Designated as safety issue: No ]
Side effects [ Time Frame: Duration of continuous infusion ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Plasma

Estimated Enrollment:	36
Study Start Date:	October 2007
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts

Group 1

In-patient in the Pediatric Intensive Care Unit
Diagnosis of Status asthmaticus
Receiving a continuous infusion of terbutaline as part of their standard of care
Ages 2 years to 6 years

Group 2

In-patient in the Pediatric Intensive Care Unit
Diagnosis of Status asthmaticus
Receiving a continuous infusion of terbutaline as part of their standard of care
Ages greater than 6 years to 12 years

Group 3

In-patient in the Pediatric Intensive Care Unit
Diagnosis of Status asthmaticus
Receiving a continuous infusion of terbutaline as part of their standard of care
Ages greater than 12 years to 18 years

Show Detailed Description

Eligibility

Ages Eligible for Study:	2 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Inpatients in Pediatric ICU with a diagnosis of status asthmaticus

Criteria

Inclusion Criteria:

Children 2 to 18 years of age.
Admission to the ICU with a diagnosis of status asthmaticus.
The pediatric intensivist taking care of the patient has decided to initiate intravenous terbutaline therapy.
An indwelling venous catheter or arterial catheter that was placed for routine ICU monitoring.
Informed consent obtained from the patient's parents or legal guardian.

Exclusion Criteria:

Existing cardiovascular disease.
History of bronchopulmonary dysplasia.
Prior inclusion in this study.
Known hypersensitivity to terbutaline, or prior adverse event associated with terbutaline.
Terbutaline use within 48 hours of initiation of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750568

Locations


United States, Kentucky
	Kosair Children's Hospital
	Louisville, Kentucky, United States, 40202

United States, Michigan
	Children's Hospital of Michigan
	Detroit, Michigan, United States, 48201

United States, Ohio
	Rainbow Babies and Childrens' Hospital
	Cleveland, Ohio, United States, 44106

Sponsors and Collaborators

Wayne State University

Investigators


Principal Investigator:	Kevin Valentine, M.D.	Children's Hospital of Michigan

Study Chair:	Mary Lieh-Lai, M.D.	Children's Hospital of Michigan; Wayne State University

More Information

Responsible Party:	Children's Hospital of Michigan ( Kevin Valentine, MD )
Study ID Numbers:	10904
First Received:	September 9, 2008
Last Updated:	September 9, 2008
ClinicalTrials.gov Identifier:	NCT00750568
Health Authority:	United States: Institutional Review Board

Keywords provided by Wayne State University:

Bronchial asthma

Asthma, bronchial

Status Asthmaticus

Terbutaline sulfate

Study placed in the following topic categories:

Hypersensitivity

Respiratory Tract Diseases

Status Asthmaticus

Hypersensitivity, Immediate

Asthma

Terbutaline

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Adrenergic beta-Agonists

Bronchial Diseases

Immune System Diseases

Sympathomimetics

Physiological Effects of Drugs

Anti-Asthmatic Agents

Reproductive Control Agents

Adrenergic Agonists

Pharmacologic Actions

Tocolytic Agents

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	Wayne State University
Information provided by:	Wayne State University
ClinicalTrials.gov Identifier:	NCT00750568