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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06169774
Other study ID # IRB23-1285
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date January 15, 2027

Study information

Verified date May 2024
Source University of Chicago
Contact Dejan Micic, MD
Phone (773) 702-6140
Email dmicic@bsd.uchicago.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to develop an educational video addressing the aseptic techniques to safely handle central catheters for administrating parenteral nutrition at home.


Description:

Home parenteral nutrition is an alternative form of providing nutrition to people whose digestive systems either can't absorb or tolerate food eaten by mouth. Parenteral nutrition provides liquid nutrients, including carbohydrates, proteins, fats, vitamins, minerals and electrolytes. In recent years, more emphasis has been placed on delivering parenteral nutrition to patients at home. Studies have shown that patients receiving home parenteral nutrition are at higher risk for bloodstream infections compared to other patients with chronic infusion needs. Catheter-related bloodstream infection is a major cause of mortality and morbidity in patients receiving parenteral nutrition. It is important to maintain safe vascular access to prevent life-threatening complications. This study aims to assess the effectiveness of the video training on the rate of catheter related bloodstream infection over a 12-month period of time.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date January 15, 2027
Est. primary completion date January 15, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Taking home parenteral nutrition for the first time - Willing to self-administer parenteral nutrition - Age = 18 yrs - Able to provide informed consent - Able speak and understand English Exclusion Criteria: - Already taking home parenteral nutrition - not willing to self-administer parenteral nutrition - Age < 18 years-old - Unable to provide informed consent - Non-English speakers

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Educational video
Watch the 17-minute educational video as many times as needed within a 12-month period.

Locations

Country Name City State
United States University of Chicago Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quantitative analysis of catheter related bloodstream infection (CRBI) events Change in number of CRBI events measured by complete blood count test. baseline-12 months
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