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Sodium Bicarbonate Catheter Lock for Intestinal Failure

Phase 2
Recruiting
Research Sponsored by Riad Rahhal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how a daily "lock" of sodium bicarbonate in central venous catheters can reduce infection risk for children with intestinal failure.

Who is the study for?
This trial is for children under 18 with intestinal failure who need daily IV nutrition or hydration through a central venous catheter. They must have had at least one previous infection related to their catheter, confirmed by blood culture.
What is being tested?
The study tests the use of an 8.4% sodium bicarbonate lock solution in the catheters of these children when not in use for feeding or hydration, aiming to reduce infections.
What are the potential side effects?
Potential side effects may include irritation at the catheter site, changes in blood pH levels due to absorption of bicarbonate, and possible interactions with other medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of catheter related bloodstream infections

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: BaselineExperimental Treatment1 Intervention
Patient on heparin locks when off venous nutrition

Find a Location

Who is running the clinical trial?

Riad RahhalLead Sponsor

Media Library

Baseline Clinical Trial Eligibility Overview. Trial Name: NCT05813535 — Phase 2
Intestinal Failure-associated Liver Disease Research Study Groups: Baseline
Intestinal Failure-associated Liver Disease Clinical Trial 2023: Baseline Highlights & Side Effects. Trial Name: NCT05813535 — Phase 2
Baseline 2023 Treatment Timeline for Medical Study. Trial Name: NCT05813535 — Phase 2
~5 spots leftby Nov 2025
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