Registry for Patients Receiving Intravenous Nutrition at Home

NCT ID: NCT02299466

Last Updated: 2022-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-12-31

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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The HTPN Registry is website based. Only users inside of Canada will be able to access the website. All data is held in Ontario, Canada and is governed by Ontario and Canadian privacy and security laws. The entry point into the registry will be through a website www.htpnregistry.ca, using a specific HTPN program password for data entry. A code and date of birth will be used to identify each patient. Patient data will be kept confidential and be entered by a member of the TPN team from each participating program. Participating programs will have access to their own database and will be able to compare their patient population to the one of the entire registry. Data entered into the registry will include: 1) Patient demography 2) Nutritional assessment 3) Medications 4) Indications for HTPN 5) Gastrointestinal anatomy following surgeries 6) HTPN regimen 7) Current blood work 8) Vascular access 9) Hospitalizations 10) Survival, 11) Liver complications 12) Metabolic bone disease 13) quality of life. In addition, information regarding each HTPN program will be captured: organization of the TPN team, number of patients under the program, diagnosis and reasons for HTPN, source of funding, geographical coverage, home care utilization, providers. Data will be entered every two years by the one or more HTPN staff monitoring the patients. The data can be entered directly into the website or case report forms can be used to collect the data from the patient charts and facilitate data input into the website.

All patients will be followed prospectively until discontinuation of TPN or death. Descriptive statistics will be performed.

For the entire HTPN population, probability of survival, chronic cholestasis, complicated home parenteral nutrition related liver disease, line infection and metabolic bone disease will be calculated using the Kaplan-Meier method. As of February 2014, 433 patients (85 from UHN) have been entered into the Canadian HTPN registry. The recruitment and data collection is expected to continue for at least 5 more years (until 2019). Participating HTPN programs are: Toronto (Toronto General Hospital, St. Michael's Hospital), Hamilton (Hamilton Health Sciences),Winnipeg (St. Boniface General Hospital), Edmonton (Capital Health/University Of Alberta), Calgary (Foothills Medical Centre), British Columbia (BC Home Parenteral Nutrition Program) and Montreal (McGill University).

Conditions

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Parenteral Nutrition, Home

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Nutrition Society

OTHER

Sponsor Role collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role collaborator

Ontario Medical Supply

UNKNOWN

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Johane Allard

MD, FRCPC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Johane Allard, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Foothills Medical Centre

Calgary, Alberta, Canada

Site Status RECRUITING

Captial Health/University Of Alberta

Edmonton, Alberta, Canada

Site Status RECRUITING

BC Home Parenteral Nutrition Program

Vancouver, British Columbia, Canada

Site Status RECRUITING

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status RECRUITING

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Hopital St-Luc

Montreal, Quebec, Canada

Site Status RECRUITING

McGill University

Montreal, Quebec, Canada

Site Status RECRUITING

Hotel-Dieu de Quebec

Québec, Quebec, Canada

Site Status RECRUITING

Saskatchewan Adult HTPN Program

Regina, Saskatchewan, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Johane Allard, MD,FRCPC

Role: CONTACT

416-340-5159

Katherine JP Schwenger, BASc, MAN, RD, PhD

Role: CONTACT

+1-416-340-4413

Facility Contacts

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Maitreyi Raman, MD

Role: primary

403-943-2580

Sari Czink, RD

Role: backup

403-944-1638

Leah Gramlich, MD

Role: primary

780-735-6839

Holly Ames, RD

Role: backup

780-407-6021

Scott Whittaker, MD

Role: primary

604-688-6332 x226

Holly van Heukelom

Role: backup

604-806-9808

Donald Duerksen, MD

Role: primary

David Armstrong, MD

Role: primary

Suzanne Hansen, RD

Role: backup

905-521-2100 ext. 75358

Khursheed Jeejeebhoy, MD

Role: primary

416-864-5348

Brian Jurewitsch, RN

Role: backup

416.864.5431

Louise D'Aoust, MD

Role: primary

514-890-8000

Errol Marliss, MD

Role: primary

514) 843-1665

Sylvie LeBourdias, RN

Role: backup

514-934-1934 ext. 35392

Marie-France Boudreault, RN

Role: primary

418-525-4444

Danielle Stevenson, RN

Role: primary

+1-306-766-2746

References

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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.

Reference Type RESULT
PMID: 24347531 (View on PubMed)

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.

Reference Type RESULT
PMID: 23064256 (View on PubMed)

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.

Reference Type RESULT
PMID: 22829428 (View on PubMed)

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.

Reference Type RESULT
PMID: 22382342 (View on PubMed)

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.

Reference Type RESULT
PMID: 22326909 (View on PubMed)

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.

Reference Type RESULT
PMID: 22301331 (View on PubMed)

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.

Reference Type RESULT
PMID: 17948134 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34229267 (View on PubMed)

Other Identifiers

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03-0845-AE

Identifier Type: -

Identifier Source: org_study_id

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