Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01760408
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):
Sustain, LLC of the American Society for Parenteral and Enteral Nutrition

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
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
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:

Other Publications:

Layout table for additonal information
Responsible Party: Sustain, LLC of the American Society for Parenteral and Enteral Nutrition
ClinicalTrials.gov Identifier: NCT01760408    
Other Study ID Numbers: SustainHPN2011
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016