Clinical trial NCT02299466: Registry for Patients Receiving Intravenous Nutrition at Home
Official title: Home Total Parenteral Nutrition (HTPN) in Canada: A New Website Based Patient Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parenteral Nutrition, Home
Keywords: parenteral nutrition
complications
indications
long-term administration
HTPN
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Nutrition Society
name: Baxter Healthcare Corporation
name: Ontario Medical Supply
First posted: 2014-11-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving home total parenteral nutrition (HTPN)

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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Nutritional status
timeFrame: bi-annually up to 10 years, discontinuation of HTPN or death
Secondary outcomes:
measure: Patient characteristics
timeFrame: baseline
measure: Medications
timeFrame: bi-annually up to 10 years, discontinuation of HTPN or death
measure: Indications for HTPN
timeFrame: bi-annually up to 10 years, discontinuation of HTPN or death
measure: Gastrointestinal anatomy
timeFrame: bi-annually up to 10 years, discontinuation of HTPN or death
measure: HTPN regimen
timeFrame: bi-annually up to 10 years, discontinuation of HTPN or death
measure: Current blood work
timeFrame: bi-annually up to 10 years, discontinuation of HTPN or death
measure: Vascular access
timeFrame: bi-annually up to 10 years, discontinuation of HTPN or death
measure: Hospitalizations
timeFrame: bi-annually up to 10 years, discontinuation of HTPN or death
measure: Survival
timeFrame: bi-annually up to 10 years, discontinuation of HTPN or death
measure: Liver complications
timeFrame: bi-annually up to 10 years, discontinuation of HTPN or death
measure: Metabolic Bone Disease
timeFrame: bi-annually up to 10 years, discontinuation of HTPN or death
measure: Quality of life based on Karnofsky performance scale
timeFrame: bi-annually up to 10 years, discontinuation of HTPN or death
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: Captial Health/University Of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: BC Home Parenteral Nutrition Program
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montréal
country: Canada
facility: Hopital St-Luc
state: Quebec
city: Montréal
country: Canada
facility: McGill University
state: Quebec
city: Québec
country: Canada
facility: Hotel-Dieu de Quebec
state: Quebec
city: Regina
country: Canada
facility: Saskatchewan Adult HTPN Program
state: Saskatchewan
Study officials:
affiliation: University Health Network, Toronto
name: Johane Allard, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.