Registry for Patients Receiving Intravenous Nutrition at Home (HTPN)

November 1, 2022 updated by: Johane Allard, University Health Network, Toronto

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.

Study Overview

Status

Recruiting

Conditions

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).

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving home total parenteral nutrition (HTPN)

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional status
Time Frame: bi-annually up to 10 years, discontinuation of HTPN or death
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
Time Frame: baseline
Age, sex, medical history
baseline
Medications
Time Frame: 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
bi-annually up to 10 years, discontinuation of HTPN or death
Indications for HTPN
Time Frame: bi-annually up to 10 years, discontinuation of HTPN or death
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
Time Frame: bi-annually up to 10 years, discontinuation of HTPN or death
Anatomy as described in medical records
bi-annually up to 10 years, discontinuation of HTPN or death
HTPN regimen
Time Frame: bi-annually up to 10 years, discontinuation of HTPN or death
Energy, amino acids, lipids, fluid, electrolytes, vitamins, trace elements
bi-annually up to 10 years, discontinuation of HTPN or death
Current blood work
Time Frame: 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
bi-annually up to 10 years, discontinuation of HTPN or death
Vascular access
Time Frame: 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)
bi-annually up to 10 years, discontinuation of HTPN or death
Hospitalizations
Time Frame: bi-annually up to 10 years, discontinuation of HTPN or death
Number/year and TPN related or not TPN related
bi-annually up to 10 years, discontinuation of HTPN or death
Survival
Time Frame: bi-annually up to 10 years, discontinuation of HTPN or death
Alive, death: causes, TPN-related or not TPN-related
bi-annually up to 10 years, discontinuation of HTPN or death
Liver complications
Time Frame: bi-annually up to 10 years, discontinuation of HTPN or death
Diagnosis, abdominal ultrasound results, liver biopsy results
bi-annually up to 10 years, discontinuation of HTPN or death
Metabolic Bone Disease
Time Frame: bi-annually up to 10 years, discontinuation of HTPN or death
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
Time Frame: bi-annually up to 10 years, discontinuation of HTPN or death
Karnofsky performance scale (0-100 point scale)
bi-annually up to 10 years, discontinuation of HTPN or death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Baxter Healthcare Corporation
Canadian Nutrition Society
Ontario Medical Supply

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2005

Primary Completion (ANTICIPATED)

December 1, 2029

Study Completion (ANTICIPATED)

December 1, 2029

Study Registration Dates

First Submitted

October 24, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (ESTIMATE)

November 24, 2014

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 03-0845-AE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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