Registry for Patients Receiving Intravenous Nutrition at Home

Parenteral Nutrition, Home Clinical Trial

— HTPN  

Official title:

Home Total Parenteral Nutrition (HTPN) in Canada: A New Website Based Patient Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02299466
• Other study ID #: 03-0845-AE
• Status: Recruiting
• Start date: December 2005
• Est. completion date: December 2029

Study information

• Verified date: November 2022
• Source: University Health Network, Toronto
• Contact: Johane Allard, MD,FRCPC
• Phone: 416-340-5159
• Email: johane.allard[@]uhn.on.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2029
• Est. primary completion date: December 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Parenteral Nutrition, Home

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Captial Health/University Of Alberta	Edmonton	Alberta
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	Hopital St-Luc	Montréal	Quebec
Canada	McGill University	Montréal	Quebec
Canada	Hotel-Dieu de Quebec	Québec	Quebec
Canada	Saskatchewan Adult HTPN Program	Regina	Saskatchewan
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	BC Home Parenteral Nutrition Program	Vancouver	British Columbia
Canada	St. Boniface General Hospital	Winnipeg	Manitoba

Sponsors (4)

Lead Sponsor	Collaborator
University Health Network, Toronto	Baxter Healthcare Corporation, Canadian Nutrition Society, Ontario Medical Supply

Country where clinical trial is conducted

Canada, 

References & Publications (7)

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 Enter — View 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. — View 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 — View 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 — View 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. Review. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional status	Body weight, body mass index	bi-annually up to 10 years, discontinuation of HTPN or death
Secondary	Patient characteristics	Age, sex, medical history	baseline
Secondary	Medications	Immunosuppressors, motility agents, antidiarrheal, sedatives, antidepressors, anticoagulants, insulin, inhibitors of acid secretion, medication to treat liver disease (eg. urso, carnitine, choline…), medication to treat metabolic bone disease (eg. iv/oral calcium, vitamin D, biphosphonate, calcitonin,… are collected from the charts	bi-annually up to 10 years, discontinuation of HTPN or death
Secondary	Indications for HTPN	Short bowel, motility disorder, cancer, surgical complications, pancreatic disorders, other causes of malabsorption	bi-annually up to 10 years, discontinuation of HTPN or death
Secondary	Gastrointestinal anatomy	Anatomy as described in medical records	bi-annually up to 10 years, discontinuation of HTPN or death
Secondary	HTPN regimen	Energy, amino acids, lipids, fluid, electrolytes, vitamins, trace elements	bi-annually up to 10 years, discontinuation of HTPN or death
Secondary	Current blood work	Complete blood count , biochemistry including liver enzymes, total protein, albumin, prealbumin, vit B12, red blood cell folate, iron studies,international normalized ratio /prothrombin time /partial thromboplastin time , cholesterol, triglycerides, trace elements;parathyroid hormone , 24-hr urine oxalate	bi-annually up to 10 years, discontinuation of HTPN or death
Secondary	Vascular access	type of catheter, number of lumens, changes in vascular access, complications (line sepsis, occlusion)	bi-annually up to 10 years, discontinuation of HTPN or death
Secondary	Hospitalizations	Number/year and TPN related or not TPN related	bi-annually up to 10 years, discontinuation of HTPN or death
Secondary	Survival	Alive, death: causes, TPN-related or not TPN-related	bi-annually up to 10 years, discontinuation of HTPN or death
Secondary	Liver complications	Diagnosis, abdominal ultrasound results, liver biopsy results	bi-annually up to 10 years, discontinuation of HTPN or death
Secondary	Metabolic Bone Disease	Bone mineral density results, fracture risk and reported fractures	bi-annually up to 10 years, discontinuation of HTPN or death
Secondary	Quality of life based on Karnofsky performance scale	Karnofsky performance scale (0-100 point scale)	bi-annually up to 10 years, discontinuation of HTPN or death