Home Inotropic Therapy in Children

Terminated

• Conditions: Congenital Disorders

• Registration Number: NCT00327899
• Lead Sponsor: Children's Healthcare of Atlanta

Brief 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.

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 Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-05-18
• Study First Submitted QC: 2006-05-18
• Study First Posted: 2006-05-19
• Study Completion: 2007-05
• Status Verified: 2007-11
• Last Update Submitted: 2011-11-18
• Last Update Posted: 2011-11-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Receiving inotropic support at home
• Choa patients with Coram Healthcare only
• medical charts between 2.2.2004 and 12.31.2005

Read More

Exclusion Criteria

• those who do not meet inclusion criteria

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States