- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00327899
Home Inotropic Therapy in Children
Inotropic therapy is a well-established practice for children with advanced congestive heart failure (CHF). Inotropes are intravenous medications to help the heart pump stronger and prolong life while awaiting heart transplantation. Traditionally children have been maintained on inotropic therapy in the hospital under close, monitored supervision. The United Network for Organ Sharing (UNOS), which governs organ distribution, has now changed listing criteria allowing patients awaiting heart transplantation to be discharged to home, yet maintaining a higher status on the waiting list. In adults, home inotropic therapy has been shown to be a safe and cost-effective bridge to transplantation. To date, there are no data on the use of home inotropic therapy in children.
Hypothesis:
We request to do a retrospective chart review of patients receiving this therapy to determine safety and efficacy of continuous ambulatory home inotropic therapy in children.
Study Overview
Status
Conditions
Detailed Description
Hypothesis:
We request to do a retrospective chart review of patients receiving this therapy to determine safety and efficacy of continuous ambulatory home inotropic therapy in children.
Methods:
Data will be obtained from CHOA and Coram Home Healthcare, Inc over a two year period, January 1, 2004 through December 31, 2005. Data will be collected on approximately 35 children aged 0-18 years receiving therapy. The length of therapy, type of therapy, therapy-related complications, number of readmissions, deaths at home and catheter-related infections data will be collected.
Inclusion Criteria:
Receiving inotropic support at home Choa patients with Coram Healthcare only
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Receiving inotropic support at home
- Choa patients with Coram Healthcare only
- medical charts between 2.2.2004 and 12.31.2005
Exclusion Criteria:
- those who do not meet inclusion criteria
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexandria Berg, MSN, Children's Healthcare of Atlanta
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 06-129
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