NCT06169774

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
32mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Jan 2024Jan 2029

First Submitted

Initial submission to the registry

December 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2029

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

4 years

First QC Date

December 5, 2023

Last Update Submit

May 5, 2026

Conditions

Intestinal Failure

Outcome Measures

Primary Outcomes (1)

  • Quantitative analysis of catheter related bloodstream infection (CRBI) events

    Change in number of CRBI events measured by complete blood count test.

    baseline-12 months

Study Arms (2)

Educational video

EXPERIMENTAL

Participants will be asked to watch an education video addressing aseptic techniques to safely handle central catheters at home during parenteral nutrition infusions.

Other: Educational video

No educational video

NO INTERVENTION

Participants will be managed according to routine care.

Interventions

Educational videoOTHER

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

Educational video

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Already taking home parenteral nutrition
  • not willing to self-administer parenteral nutrition
  • Age \< 18 years-old
  • Unable to provide informed consent
  • Non-English speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Intestinal Failure

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Carol Semrad, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yichun Fu, MD

CONTACT

(773) 702-3075Yichun.Fu@bsd.uchicago.edu

Kristi Kearney, MD

CONTACT

(773) 834-7414Kkearney@bsd.uchicago.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2023

First Posted

December 13, 2023

Study Start

January 1, 2024

Primary Completion (Estimated)

January 15, 2028

Study Completion (Estimated)

January 15, 2029

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)