Patients Requiring Home Parenteral NutritionNCT01760408
Sustain, A.S.P.E.N. HPN Registry 2011
An observational study of Patients Requiring Home Parenteral Nutrition, run by Sustain, LLC of the American Society for Parenteral and Enteral Nutrition at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patients Requiring Home Parenteral Nutrition
- What is being tested?
- all patients on Home Parenteral Nutrition
- How many people
- 1,600 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Feb 2015
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients receiving parenteral nutrition at home
Who may be able to join
- Exclusion Criteria:patients receiving PN in long-term care or as IDPN
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SustainTM,LLC: A.S.P.E.N.'s National Patient Registry for Nutrition Care- Home Parenteral Nutrition
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.
- Being tested
- all patients on Home Parenteral Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
all patients on Home Parenteral NutritionOther
| Study group | Role | What they receive |
|---|---|---|
| Home PN - pediatric | Pediatric patients (under 18) on Home PN Receives: Other: all patients on Home Parenteral Nutrition | |
| Adult patients on Home PN | Adult patients on Home PN Receives: Other: all patients on Home Parenteral Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
catheter infection rate
catheter infection rate normalized per 1000 PN days
Measured: per 1000 PN days
Secondary outcomes (1)
rehospitalization rate
rehospitalization rate per 1000 PN days
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startFeb 2011
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patients Requiring Home Parenteral NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Sustain, LLC of the American Society for Parenteral and Enteral Nutrition
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760408
- Sponsor's protocol ID
- SustainHPN2011
- Status last verified
- Oct 2016
- First submitted
- 31 Dec 2012
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22282869Winkler 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.
PubMed 25972431
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SustainTM,LLC: A.S.P.E.N.'s National Patient Registry for Nutrition Care- Home Parenteral Nutrition
- ClinicalTrials.gov ID
- NCT01760408
- Acronym / sponsor ID
- SustainHPN2011
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Sustain, LLC of the American Society for Parenteral and Enteral NutritionUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home PN - pediatric | – | Other: all patients on Home Parenteral NutritionPediatric patients (under 18) on Home PN |
| Adult patients on Home PN | – | Other: all patients on Home Parenteral NutritionAdult patients on Home PN |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients receiving parenteral nutrition at home
Key inclusion criteria (2 listed)
- Exclusion Criteria:patients receiving PN in long-term care or as IDPN
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| all patients on Home Parenteral Nutrition | Other | Adult patients on Home PN, Home PN - pediatric |
Primary outcome
catheter infection rate
Time frame: per 1000 PN days
catheter infection rate normalized per 1000 PN days
1 secondary outcome
rehospitalization rate
Time frame: ongoing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Background: PubMed 22282869Guenter 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.
- Results publication: PubMed 25972431Winkler 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Requiring Home Parenteral Nutrition, run by Sustain, LLC of the American Society for Parenteral and Enteral Nutrition at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
catheter infection rate (time frame: per 1000 PN days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01760408, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2016.