NCT00750568

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

September 10, 2008

Status Verified

August 1, 2008

Enrollment Period

1.8 years

First QC Date

September 9, 2008

Last Update Submit

September 9, 2008

Conditions

Status Asthmaticus

Keywords

Bronchial asthmaAsthma, bronchialStatus AsthmaticusTerbutaline sulfate

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of continuous terbutaline infusion

    Prior to infusion; 20 minutes, 2, 4, 6, 8, 10, 12 hours post infusion

Secondary Outcomes (3)

  • Modified Pulmonary Index Score (MPIS)

    Assess every 4 hours while IV terbutaline is infusing, continuing for 8 hours after the infusion is discontinued

  • Physiologic parameters

    Prior to terbutaline, 20 minutes post, then hourly during infusion

  • Side effects

    Duration of continuous infusion

Study Arms (3)

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

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Inpatients in Pediatric ICU with a diagnosis of status asthmaticus

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Rainbow Babies and Childrens' Hospital

Cleveland, Ohio, 44106, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Status AsthmaticusAsthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Kevin Valentine, M.D.

    Children's Hospital of Michigan

    PRINCIPAL INVESTIGATOR

  • Mary Lieh-Lai, M.D.

    Children's Hospital of Michigan; Wayne State University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2008

First Posted

September 10, 2008

Study Start

October 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

September 10, 2008

Record last verified: 2008-08

Locations

US(3)