NCT05813535

Brief Summary

We plan to include children with intestinal failure, a condition where the gut is not functioning properly, leading these children to need central venous catheters (line that goes through the skin into the blood stream) for nutritional support and hydration. Such patients have a very high risk for catheter infection. The study will include placing an agent (sodium bicarbonate) into the central catheter when the catheter is not in use. This is referred to as a lock. The lock would be used daily and removed when patients start their nutritional support and hydration through the catheter.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 14, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

March 20, 2023

Last Update Submit

November 14, 2023

Conditions

Intestinal FailureCRBSI - Catheter Related Bloodstream Infection

Outcome Measures

Primary Outcomes (1)

  • Rate of catheter related bloodstream infections

    Number of infections per 1000 catheter days

    Through study completion, an average of 1 year

Study Arms (1)

Baseline

OTHER

Patient on heparin locks when off venous nutrition

Drug: Sodium bicarb lock

Interventions

Sodium bicarb lockDRUG

8.4% sodium bicarb locks when off venous nutrition

Baseline

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subject fulfills diagnosis of intestinal failure with a central venous catheter in place used daily on outpatient basis for intravenous nutrition and /or intravenous hydration
  • Subject is less than 18 years of age at the time of study entry
  • Subject with history of at least 1 documented catheter related blood stream infection (verified by blood culture)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Intestinal Failure

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Riad Rahhal, MD

CONTACT

+1 319 356 2950riad-rahhal@uiowa.edu

Kathy Bell

CONTACT

kathy-bell@uiowa.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 20, 2023

First Posted

April 14, 2023

Study Start

December 1, 2022

Primary Completion

January 1, 2024

Study Completion

December 1, 2024

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

US(1)