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NCT00327899 Clinical Trial

Home Inotropic Therapy in Children

Congenital Disorders Clinical Trial

Official title:
Home Inotropic Therapy in Children

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00327899
Other study ID # 06-129
Secondary ID
Status Terminated
Phase N/A
First received May 18, 2006
Last updated November 18, 2011
Start date March 2006
Est. completion date May 2007

Study information
Verified date November 2007
Source Children's Healthcare of Atlanta
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility
Status Terminated
Enrollment 13
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility 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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Healthcare of Atlanta Atlanta Georgia

Sponsors (1)
Lead Sponsor Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

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