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

Patients Requiring Home Parenteral Nutrition Clinical Trial

Official title:

SustainTM,LLC: A.S.P.E.N.'s National Patient Registry for Nutrition Care- Home Parenteral Nutrition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01760408
• Other study ID #: SustainHPN2011
• Status: Completed
• Phase: N/A
• First received: December 31, 2012
• Last updated: October 12, 2016
• Start date: February 2011
• Est. completion date: February 2015

Study information

• Verified date: October 2016
• Source: Sustain, LLC of the American Society for Parenteral and Enteral Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:must receive PN at home -

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Patients Requiring Home Parenteral Nutrition

Intervention

Other:
• all patients on Home Parenteral Nutrition

Locations

Country	Name	City	State
United States	A.S.P.E.N.	Silver Spring	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sustain, LLC of the American Society for Parenteral and Enteral Nutrition

Country where clinical trial is conducted

United States, 

References & Publications (2)

Guenter P, Robinson L, DiMaria-Ghalili RA, Lyman B, Steiger E, Winkler MF. Development of Sustain™: A.S.P.E.N.'s National Patient Registry for Nutrition Care. JPEN J Parenter Enteral Nutr. 2012 Jul;36(4):399-406. doi: 10.1177/0148607111432760. Epub 2012 Jan 26. — View Citation

Winkler MF, DiMaria-Ghalili RA, Guenter P, Resnick HE, Robinson L, Lyman B, Ireton-Jones C, Banchik LH, Steiger E. Characteristics of a Cohort of Home Parenteral Nutrition Patients at the Time of Enrollment in the Sustain Registry. JPEN J Parenter Enteral — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	catheter infection rate	catheter infection rate normalized per 1000 PN days	per 1000 PN days	Yes
Secondary	rehospitalization rate	rehospitalization rate per 1000 PN days	ongoing	No

External Links

•   Sustain webpage on A.S.P.E.N. website