Parenteral Nutrition, HomeHTPNNCT02299466
Registry for Patients Receiving Intravenous Nutrition at Home
An observational study of Parenteral Nutrition, Home, run by University Health Network, Toronto at 10 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parenteral Nutrition, Home
- How many people
- 1,000 participants
- Where
- 10 sitesCanada
- Study dates
- Dec 2005to Dec 2029
- How long will I take part?
- 15 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving home total parenteral nutrition (HTPN)
Who may be able to join
- Patients with long-term administration of home total parenteral nutrition Age >18 years
Who cannot join
- None
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Canada10 sites, 10 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta
Maitreyi Raman, MD, 403-943-2580, mkothand@ucalgary.ca
Sari Czink, RD, 403-944-1638, Sari.czink@calgaryhealthregion.ca
- Recruiting
Captial Health/University Of Alberta
Edmonton, Alberta
Leah Gramlich, MD, 780-735-6839, eah.gramlich@ualberta.ca
Holly Ames, RD, 780-407-6021, holly.ames@albertahealthservices.ca
- Recruiting
Hamilton Health Sciences
Hamilton, Ontario
David Armstrong, MD, armstro@mcmaster.ca
Suzanne Hansen, RD, 905-521-2100 ext. 75358, shansen@hhsc.ca
- Recruiting
Hopital St-Luc
Montreal, Quebec, H2X 0C1
Louise D'Aoust, MD, 514-890-8000, louise_daoust@sympatico.ca
- Recruiting
McGill University
Montreal, Quebec, H3G 1A4
Errol Marliss, MD, 514) 843-1665, marliss.errol@muhc.mcgill.ca
Sylvie LeBourdias, RN, 514-934-1934 ext. 35392, Sylvie.Lebourdais@muhc.mcgill.ca
- Recruiting
Hotel-Dieu de Quebec
Québec, Quebec
Marie-France Boudreault, RN, 418-525-4444, marie-france.boudreault@chuq.qc.ca
- Recruiting
Saskatchewan Adult HTPN Program
Regina, Saskatchewan, S4T 1A5
Danielle Stevenson, RN, +1-306-766-2746, Danielle.Stevenson@rqhealth.ca
- Recruiting
St. Michael's Hospital
Toronto, Ontario
Khursheed Jeejeebhoy, MD, 416-864-5348, khushjeejeebhoy@compuserve.com
Brian Jurewitsch, RN, 416.864.5431, jurewitschb@smh.toronto.on.ca
- Recruiting
BC Home Parenteral Nutrition Program
Vancouver, British Columbia
Scott Whittaker, MD, 604-688-6332 x226, scottwhittaker@mac.com
Holly van Heukelom, 604-806-9808, HvanHeukelom@providencehealth.bc.ca
- Recruiting
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
Donald Duerksen, MD, dduerkse@sbgh.mb.ca
About this study
Official title: Home Total Parenteral Nutrition (HTPN) in Canada: A New Website Based Patient Registry
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.
Read the 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).
- Conditions
- Parenteral Nutrition, Home
- Keywords
- parenteral nutrition, complications, indications, long-term administration, HTPN
- Medical subject headings
- Hyperphagia
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status
Body weight, body mass index
Measured: bi-annually up to 10 years, discontinuation of HTPN or death
Secondary outcomes (12)
Patient characteristics
Age, sex, medical history
Measured: 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
Measured: 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
Measured: bi-annually up to 10 years, discontinuation of HTPN or death
Gastrointestinal anatomy
Anatomy as described in medical records
Measured: bi-annually up to 10 years, discontinuation of HTPN or death
HTPN regimen
Energy, amino acids, lipids, fluid, electrolytes, vitamins, trace elements
Measured: 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
Measured: 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)
Measured: bi-annually up to 10 years, discontinuation of HTPN or death
Hospitalizations
Number/year and TPN related or not TPN related
Measured: bi-annually up to 10 years, discontinuation of HTPN or death
Survival
Alive, death: causes, TPN-related or not TPN-related
Measured: bi-annually up to 10 years, discontinuation of HTPN or death
Liver complications
Diagnosis, abdominal ultrasound results, liver biopsy results
Measured: bi-annually up to 10 years, discontinuation of HTPN or death
Metabolic Bone Disease
Bone mineral density results, fracture risk and reported fractures
Measured: 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)
Measured: bi-annually up to 10 years, discontinuation of HTPN or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startDec 2005
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Parenteral Nutrition, HomeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Nutrition Society, Baxter Healthcare Corporation, Ontario Medical Supply
- Responsible party
- Principal investigator, Johane Allard, University Health Network, Toronto
- Investigators
- Johane Allard, MD, FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299466
- Sponsor's protocol ID
- 03-0845-AE
- Acronym
- HTPN
- Status last verified
- Nov 2022
- First submitted
- 24 Oct 2014
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24347531Abdalian 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.
PubMed 23064256Abdalian 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.
PubMed 22829428Jawa 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.
PubMed 22382342Fernandes 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.
PubMed 22326909Aljarallah 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.
PubMed 22301331Raman 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.
PubMed 17948134Clermont-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.
PubMed 34229267