Home Inotropic Therapy in Children

This study has been terminated.
(Per PI instruction.)
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00327899
First received: May 18, 2006
Last updated: November 18, 2011
Last verified: November 2007

May 18, 2006
November 18, 2011
March 2006
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Complete list of historical versions of study NCT00327899 on ClinicalTrials.gov Archive Site
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Home Inotropic Therapy in Children
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.

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

Observational
Time Perspective: Retrospective
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Non-Probability Sample

Choa patients' medical charts between 2.2.04 and 12.31.05 with Coram Healthcare only. These patients would have received inotropic support at home.

Congenital Disorders
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
May 2007
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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

Exclusion Criteria:

  • those who do not meet inclusion criteria
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00327899
06-129
No
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Children's Healthcare of Atlanta
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Principal Investigator: Alexandria Berg, MSN Children's Healthcare of Atlanta
Children's Healthcare of Atlanta
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP