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Sustain, A.S.P.E.N. HPN Registry 2011

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ClinicalTrials.gov Identifier: NCT01760408
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) developed a Web-based registry for nutrition care launched in early 2011, initially focusing on the home parenteral nutrition (HPN) patient population. The purpose of Sustain is to collect information regarding the patients and populations who require HPN in the United States, measure outcomes associated with HPN, allow institutional benchmarking against the aggregate data, and publish the findings to improve the quality of care for patients receiving HPN. The registry is open to all sites (hospital and home based) who care for new or existing HPN patients.

Condition or disease Intervention/treatment
Patients Requiring Home Parenteral Nutrition Other: all patients on Home Parenteral Nutrition

Study Design

Study Type : Observational [Patient Registry]
Actual Enrollment : 1600 participants
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: SustainTM,LLC: A.S.P.E.N.'s National Patient Registry for Nutrition Care- Home Parenteral Nutrition
Study Start Date : February 2011
Primary Completion Date : February 2015
Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Home PN - pediatric
Pediatric patients (under 18) on Home PN
Other: all patients on Home Parenteral Nutrition
Adult patients on Home PN
Adult patients on Home PN
Other: all patients on Home Parenteral Nutrition


Outcome Measures

Primary Outcome Measures :
  1. catheter infection rate [ Time Frame: per 1000 PN days ]
    catheter infection rate normalized per 1000 PN days


Secondary Outcome Measures :
  1. rehospitalization rate [ Time Frame: ongoing ]
    rehospitalization rate per 1000 PN days


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients receiving parenteral nutrition at home
Criteria

Inclusion Criteria:must receive PN at home -

Exclusion Criteria:patients receiving PN in long-term care or as IDPN

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760408


Locations
United States, Maryland
A.S.P.E.N.
Silver Spring, Maryland, United States, 20910
Sponsors and Collaborators
Sustain, LLC of the American Society for Parenteral and Enteral Nutrition