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

This study is currently recruiting participants.
Verified December 2012 by Sustain, LLC of the American Society for Parenteral and Enteral Nutrition
Sponsor:
Information provided by (Responsible Party):
Sustain, LLC of the American Society for Parenteral and Enteral Nutrition
ClinicalTrials.gov Identifier:
NCT01760408
First received: December 31, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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 Intervention
Patients Requiring Home Parenteral Nutrition
 Other: all patients on Home Parenteral Nutrition

Study Type: Observational [Patient Registry]
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sustain, LLC of the American Society for Parenteral and Enteral Nutrition:

Primary Outcome Measures:
  • catheter infection rate [ Time Frame: per 1000 PN days ] [ Designated as safety issue: Yes ]
    catheter infection rate normalized per 1000 PN days


Secondary Outcome Measures:
  • rehospitalization rate [ Time Frame: ongoing ] [ Designated as safety issue: No ]
    rehospitalization rate per 1000 PN days


Estimated Enrollment: 10000
Study Start Date: February 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760408

Contacts
Contact: Peggi Guenter, PhD, RN 610-649-7994 peggig@aspen.nutr.org
Contact: Katy Hanley 301-920-9133 katyh@aspen.nutr.org

Locations
United States, Maryland
A.S.P.E.N. Recruiting
Silver Spring, Maryland, United States, 20910
Contact: Peggi Guenter, PhD            
Principal Investigator: Peggi Guenter, PhD, RN            
Sponsors and Collaborators
Sustain, LLC of the American Society for Parenteral and Enteral Nutrition
  More Information

Additional Information:
Sustain webpage on A.S.P.E.N. website  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Sustain, LLC of the American Society for Parenteral and Enteral Nutrition
ClinicalTrials.gov Identifier: NCT01760408     History of Changes
Other Study ID Numbers: SustainHPN2011
Study First Received: December 31, 2012
Last Updated: December 31, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 21, 2013