Registry for Patients Receiving Intravenous Nutrition at Home
- Conditions
- Parenteral Nutrition, Home
- Registration Number
- NCT02299466
- Lead Sponsor
- University Health Network, Toronto
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- Patients with long-term administration of home total parenteral nutrition Age >18 years
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Nutritional status bi-annually up to 10 years, discontinuation of HTPN or death Body weight, body mass index
- Secondary Outcome Measures
Name Time Method Patient characteristics baseline Age, sex, medical history
Medications bi-annually up to 10 years, discontinuation of HTPN or death 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
HTPN regimen bi-annually up to 10 years, discontinuation of HTPN or death Energy, amino acids, lipids, fluid, electrolytes, vitamins, trace elements
Current blood work bi-annually up to 10 years, discontinuation of HTPN or death 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
Survival bi-annually up to 10 years, discontinuation of HTPN or death Alive, death: causes, TPN-related or not TPN-related
Liver complications bi-annually up to 10 years, discontinuation of HTPN or death Diagnosis, abdominal ultrasound results, liver biopsy results
Metabolic Bone Disease bi-annually up to 10 years, discontinuation of HTPN or death Bone mineral density results, fracture risk and reported fractures
Vascular access bi-annually up to 10 years, discontinuation of HTPN or death type of catheter, number of lumens, changes in vascular access, complications (line sepsis, occlusion)
Hospitalizations bi-annually up to 10 years, discontinuation of HTPN or death Number/year and TPN related or not TPN related
Quality of life based on Karnofsky performance scale bi-annually up to 10 years, discontinuation of HTPN or death Karnofsky performance scale (0-100 point scale)
Indications for HTPN bi-annually up to 10 years, discontinuation of HTPN or death Short bowel, motility disorder, cancer, surgical complications, pancreatic disorders, other causes of malabsorption
Gastrointestinal anatomy bi-annually up to 10 years, discontinuation of HTPN or death Anatomy as described in medical records
Trial Locations
- Locations (10)
BC Home Parenteral Nutrition Program
🇨🇦Vancouver, British Columbia, Canada
Saskatchewan Adult HTPN Program
🇨🇦Regina, Saskatchewan, Canada
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
Hopital St-Luc
🇨🇦Montréal, Quebec, Canada
McGill University
🇨🇦Montréal, Quebec, Canada
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
Hotel-Dieu de Quebec
🇨🇦Québec, Quebec, Canada
Captial Health/University Of Alberta
🇨🇦Edmonton, Alberta, Canada