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Intravenous Terbutaline in Severe Status Asthmaticus

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ClinicalTrials.gov Identifier: NCT00750568
Recruitment Status : Unknown
Verified August 2008 by Wayne State University.
Recruitment status was:  Enrolling by invitation
First Posted : September 10, 2008
Last Update Posted : September 10, 2008
Sponsor:
Information provided by:
Wayne State University

Brief Summary:
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 or disease
Status Asthmaticus

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics and Pharmacodynamics of Terbutaline Given as a Continuous Intravenous Infusion in Severe Status Asthmaticus
Study Start Date : October 2007
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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



Primary Outcome Measures :
  1. Pharmacokinetics of continuous terbutaline infusion [ Time Frame: Prior to infusion; 20 minutes, 2, 4, 6, 8, 10, 12 hours post infusion ]

Secondary Outcome Measures :
  1. 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 ]
  2. Physiologic parameters [ Time Frame: Prior to terbutaline, 20 minutes post, then hourly during infusion ]
  3. Side effects [ Time Frame: Duration of continuous infusion ]

Biospecimen Retention:   Samples Without DNA
Plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kevin Valentine, MD, Children's Hospital of Michigan
ClinicalTrials.gov Identifier: NCT00750568     History of Changes
Other Study ID Numbers: 10904
First Posted: September 10, 2008    Key Record Dates
Last Update Posted: September 10, 2008
Last Verified: August 2008

Keywords provided by Wayne State University:
Bronchial asthma
Asthma, bronchial
Status Asthmaticus
Terbutaline sulfate

Additional relevant MeSH terms:
Status Asthmaticus
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Terbutaline
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action