8.4% Sodium Bicarbonate Locks in Intestinal Failure

Phase 2

Recruiting

• Conditions: Intestinal Failure; CRBSI - Catheter Related Bloodstream Infection
• Interventions: Drug: Sodium bicarb lock

• Registration Number: NCT05813535
• Lead Sponsor: Riad Rahhal

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.

Detailed Description

Children with intestinal failure who rely on a silicone based central venous catheter for parenteral nutrition to provide nutritional support and hydration will be invited to participate in this study. The intervention will offer use of a specific catheter lock solution (8.4% sodium bicarbonate) when the catheter is not in use. This includes daily lock use with removal of the lock at end of dwell time.

Study Timeline

• Study Start: 2022-12-01
• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-04-02
• Study First Posted: 2023-04-14
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-01
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Baseline	Sodium bicarb lock	Patient on heparin locks when off venous nutrition

Primary Outcome Measures

Name	Time	Method
Rate of catheter related bloodstream infections	Through study completion, an average of 1 year	Number of infections per 1000 catheter days

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States