NCT01760408

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 31, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

4 years

First QC Date

December 31, 2012

Last Update Submit

October 12, 2016

Conditions

Patients Requiring Home Parenteral Nutrition

Outcome Measures

Primary Outcomes (1)

  • catheter infection rate

    catheter infection rate normalized per 1000 PN days

    per 1000 PN days

Secondary Outcomes (1)

  • rehospitalization rate

    ongoing

Study Arms (2)

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

Interventions

all patients on Home Parenteral NutritionOTHER
Adult patients on Home PNHome PN - pediatric

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients receiving parenteral nutrition at home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A.S.P.E.N.

Silver Spring, Maryland, 20910, United States

Location

Related 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.

    PMID: 22282869BACKGROUND

  • 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 Nutr. 2016 Nov;40(8):1140-1149. doi: 10.1177/0148607115586575. Epub 2015 May 13.

    PMID: 25972431RESULT

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2012

First Posted

January 4, 2013

Study Start

February 1, 2011

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

October 13, 2016

Record last verified: 2016-10

Locations

US(1)