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Intravenous Terbutaline in Severe Status Asthmaticus

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by Wayne State University.
Recruitment status was:  Enrolling by invitation
Information provided by:
Wayne State University Identifier:
First received: September 9, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
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.

Status Asthmaticus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics and Pharmacodynamics of Terbutaline Given as a Continuous Intravenous Infusion in Severe Status Asthmaticus

Resource links provided by NLM:

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 ]

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 ]
  • Physiologic parameters [ Time Frame: Prior to terbutaline, 20 minutes post, then hourly during infusion ]
  • Side effects [ Time Frame: Duration of continuous infusion ]

Biospecimen Retention:   Samples Without DNA

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)
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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00750568

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
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: Kevin Valentine, MD, Children's Hospital of Michigan Identifier: NCT00750568     History of Changes
Other Study ID Numbers: 10904
Study First Received: September 9, 2008
Last Updated: September 9, 2008

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

Additional relevant MeSH terms:
Status Asthmaticus
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017