NCT02299466

Brief Summary

The purpose of study is to build a Canadian HTPN Registry to collect pertinent demographic and clinical data on the HTPN population in Canada and to determine the factors affecting survival, complications and TPN-dependency. These results will help establish standards of practice and develop future multi-center studies. This will greatly benefit the HTPN patient population.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
43mo left

Started Dec 2005

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
recruiting

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 Progress85%
Dec 2005Dec 2029

Study Start

First participant enrolled

December 1, 2005

Completed
8.9 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

24 years

First QC Date

October 24, 2014

Last Update Submit

November 1, 2022

Conditions

Parenteral Nutrition, Home

Keywords

parenteral nutritioncomplicationsindicationslong-term administrationHTPN

Outcome Measures

Primary Outcomes (1)

  • Nutritional status

    Body weight, body mass index

    bi-annually up to 10 years, discontinuation of HTPN or death

Secondary Outcomes (12)

  • Patient characteristics

    baseline

  • Medications

    bi-annually up to 10 years, discontinuation of HTPN or death

  • Indications for HTPN

    bi-annually up to 10 years, discontinuation of HTPN or death

  • Gastrointestinal anatomy

    bi-annually up to 10 years, discontinuation of HTPN or death

  • HTPN regimen

    bi-annually up to 10 years, discontinuation of HTPN or death

  • +7 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving home total parenteral nutrition (HTPN)

You may qualify if:

  • Patients with long-term administration of home total parenteral nutrition Age \>18 years

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Foothills Medical Centre

Calgary, Alberta, Canada

RECRUITING

Captial Health/University Of Alberta

Edmonton, Alberta, Canada

RECRUITING

BC Home Parenteral Nutrition Program

Vancouver, British Columbia, Canada

RECRUITING

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

RECRUITING

Hamilton Health Sciences

Hamilton, Ontario, Canada

RECRUITING

St. Michael's Hospital

Toronto, Ontario, Canada

RECRUITING

Hopital St-Luc

Montreal, Quebec, H2X 0C1, Canada

RECRUITING

McGill University

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

Hotel-Dieu de Quebec

Québec, Quebec, Canada

RECRUITING

Saskatchewan Adult HTPN Program

Regina, Saskatchewan, S4T 1A5, Canada

RECRUITING

Related Publications (8)

  • Saqui O, Fernandes G, Allard JP. Quality of life analysis during transition from stationary to portable infusion pump in home parenteral nutrition patients: a Canadian experience. Nutr Clin Pract. 2014 Feb;29(1):131-41. doi: 10.1177/0884533613516129. Epub 2013 Dec 17.

    PMID: 24347531RESULT

  • Abdalian R, Fernandes G, Duerksen D, Jeejeebhoy KN, Whittaker S, Gramlich L, Allard JP. Prescription of trace elements in adults on home parenteral nutrition: current practice based on the Canadian Home Parenteral Nutrition Registry. JPEN J Parenter Enteral Nutr. 2013 May-Jun;37(3):410-5. doi: 10.1177/0148607112463074. Epub 2012 Oct 12.

    PMID: 23064256RESULT

  • Abdalian R, Saqui O, Fernandes G, Allard JP. Effects of manganese from a commercial multi-trace element supplement in a population sample of Canadian patients on long-term parenteral nutrition. JPEN J Parenter Enteral Nutr. 2013 Jul;37(4):538-43. doi: 10.1177/0148607112454543. Epub 2012 Jul 24.

    PMID: 22829428RESULT

  • Jawa H, Fernandes G, Saqui O, Allard JP. Home parenteral nutrition in patients with systemic sclerosis: a retrospective review of 12 cases. J Rheumatol. 2012 May;39(5):1004-7. doi: 10.3899/jrheum.110896. Epub 2012 Mar 1.

    PMID: 22382342RESULT

  • Fernandes G, Kaila B, Jeejeebhoy KN, Gramlich L, Armstrong D, Allard JP. Canadian home parenteral nutrition (HPN) registry: validation and patient outcomes. JPEN J Parenter Enteral Nutr. 2012 Jul;36(4):407-14. doi: 10.1177/0148607111434599. Epub 2012 Feb 10.

    PMID: 22326909RESULT

  • Aljarallah B, Fernandes G, Jeejeebhoy KN, Gramlich LM, Whittaker JS, Armstrong D, Duerksen DR, Allard JP. The Canadian Home Total Parenteral Nutrition (HTPN) Registry: vitamin K supplementation and bone mineral density. JPEN J Parenter Enteral Nutr. 2012 Jul;36(4):415-20. doi: 10.1177/0148607111431983. Epub 2012 Feb 1.

    PMID: 22301331RESULT

  • Raman M, Gramlich L, Whittaker S, Allard JP. Canadian home total parenteral nutrition registry: preliminary data on the patient population. Can J Gastroenterol. 2007 Oct;21(10):643-8. doi: 10.1155/2007/217897.

    PMID: 17948134RESULT

  • Clermont-Dejean NM, Schwenger KJP, Salazar E, Colombo FF, Lu Z, Lou W, Gramlich L, Whittaker S, Armstrong D, Jurewitsch B, Raman M, Duerksen DR, McHattie JD, Murthy S, Allard JP. Home parenteral nutrition patients on mixed oil lipid emulsion have a higher rate of hospitalizations compare to those on soybean oil- a prospective 2-year cohort study. Clin Nutr. 2021 Jul;40(7):4616-4623. doi: 10.1016/j.clnu.2021.06.012. Epub 2021 Jun 17.

    PMID: 34229267DERIVED

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Johane Allard, MD, FRCPC

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johane Allard, MD,FRCPC

CONTACT

416-340-5159johane.allard@uhn.on.ca

Katherine JP Schwenger, BASc, MAN, RD, PhD

CONTACT

+1-416-340-4413kschweng@uhnresearch.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FRCPC

Study Record Dates

First Submitted

October 24, 2014

First Posted

November 24, 2014

Study Start

December 1, 2005

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

November 4, 2022

Record last verified: 2022-11

Locations

CA(10)