Back to results8.4% Sodium Bicarbonate Locks in Intestinal Failure
Primary Purpose
Intestinal Failure, CRBSI - Catheter Related Bloodstream Infection
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sodium bicarb lock
Sponsored by
About this trial
This is an interventional prevention trial for Intestinal Failure
Eligibility Criteria
Inclusion Criteria: 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)
Sites / Locations
- University of IowaRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Baseline
Arm Description
Patient on heparin locks when off venous nutrition
Outcomes
Primary Outcome Measures
Rate of catheter related bloodstream infections
Number of infections per 1000 catheter days
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05813535
Brief Title
8.4% Sodium Bicarbonate Locks in Intestinal Failure
Official Title
Sodium Bicarb Locks in Intestinal Failure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Riad Rahhal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Failure, CRBSI - Catheter Related Bloodstream Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Baseline
Arm Type
Other
Arm Description
Patient on heparin locks when off venous nutrition
Intervention Type
Drug
Intervention Name(s)
Sodium bicarb lock
Intervention Description
8.4% sodium bicarb locks when off venous nutrition
Primary Outcome Measure Information:
Title
Rate of catheter related bloodstream infections
Description
Number of infections per 1000 catheter days
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Riad Rahhal, MD
Phone
+1 319 356 2950
Email
riad-rahhal@uiowa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kathy Bell
Email
kathy-bell@uiowa.edu
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riad Rahhal, MD
Email
riad-rahhal@uiowa.edu
12. IPD Sharing Statement
Learn more about this trial
8.4% Sodium Bicarbonate Locks in Intestinal Failure
We'll reach out to this number within 24 hrs