Registry for Patients Receiving Intravenous Nutrition at Home

Study Overview
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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).

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

Conditions
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Parenteral Nutrition, Home

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with long-term administration of home total parenteral nutrition Age >18 years Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status | Body weight, body mass index | bi-annually up to 10 years, discontinuation of HTPN or death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient characteristics | Age, sex, medical history | baseline | 
| 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 | 
| 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 | 
| Gastrointestinal anatomy | Anatomy as described in medical records | bi-annually up to 10 years, discontinuation of HTPN or death | 
| HTPN regimen | Energy, amino acids, lipids, fluid, electrolytes, vitamins, trace elements | bi-annually up to 10 years, discontinuation of HTPN or death | 
| 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 | 
| 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 | 
| Hospitalizations | Number/year and TPN related or not TPN related | bi-annually up to 10 years, discontinuation of HTPN or death | 
| Survival | Alive, death: causes, TPN-related or not TPN-related | bi-annually up to 10 years, discontinuation of HTPN or death | 
| Liver complications | Diagnosis, abdominal ultrasound results, liver biopsy results | bi-annually up to 10 years, discontinuation of HTPN or death | 
| Metabolic Bone Disease | Bone mineral density results, fracture risk and reported fractures | bi-annually up to 10 years, discontinuation of HTPN or death | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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parenteral nutrition, complications, indications, long-term administration, HTPN