Phase 2 N=6 Prevention

8.4% Sodium Bicarbonate Locks in Intestinal Failure

Intestinal Failure · CRBSI - Catheter Related Bloodstream Infection

Bottom Line

View on ClinicalTrials.gov: NCT05813535 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2026

Primary outcome: Primary: Rate of Catheter Related Bloodstream Infections — 8.2; 3.0 infections per 1000 catheter days

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Sodium bicarb lock (Drug)
Age: Pediatric, Adult · 1+ yrs
Sex: All
Sponsor: Riad Rahhal
Primary completion: Mar 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of Catheter Related Bloodstream Infections	8.2; 3.0	—

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.

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)

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Data sourced from ClinicalTrials.gov (NCT05813535). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.