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Home Inotropic Therapy in Children

NCT ID: NCT00327899

Last Updated: 2011-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-05-31

Brief Summary

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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

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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

Conditions

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Congenital Disorders

Keywords

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pediatric congestive heart failure inotropes

Study Design

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Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Receiving inotropic support at home
* Choa patients with Coram Healthcare only
* medical charts between 2.2.2004 and 12.31.2005
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Healthcare of Atlanta

OTHER

Sponsor Role lead

Principal Investigators

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Alexandria Berg, MSN

Role: PRINCIPAL_INVESTIGATOR

Children's Healthcare of Atlanta

Locations

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Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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06-129

Identifier Type: -

Identifier Source: org_study_id