A Phase 2 interventional study of Sodium bicarb lock in Intestinal Failure and CRBSI - Catheter Related Bloodstream Infection, sponsored by Riad Rahhal. Completed at 1 site in United States. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Riad Rahhal · Phase 2, Interventional, and Prevention
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.
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.
64 studies on the registry are indexed under Intestinal Failure; 17 are open to participants now.
This study's enrollment of 6 is below the median of 38 across 42 interventional studies indexed under Intestinal Failure.
Browse Intestinal Failure studies →This is the only study on the registry with Riad Rahhal as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Patient on heparin locks when off venous nutrition
Drug: Sodium bicarb lock
8.4% sodium bicarb locks when off venous nutrition
Rate of Catheter Related Bloodstream Infections
Number of infections per 1000 catheter days
Time frame: Through study completion, an average of 1 year
| Milestone | Sodium Bicarb Lock |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
Number of infections per 1000 catheter days
| infections per 1000 catheter days | Baseline | Sodium Bicarb Locks |
|---|---|---|
| Rate of Catheter Related Bloodstream Infections | 8.2 (1.4 to 14.3) | 3.0 (0 to 11.1) |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Heparin Locks | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Sodium Bicarb Locks | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | Intervention |
|---|---|
| <=18 years | 6 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Intervention |
|---|---|
| Median | 12.3 (1.4 to 17.4) |
| Sex: Female, Male(Participants) | Intervention |
|---|---|
| Female | 3 |
| Male | 3 |
| Race and Ethnicity Not Collected(Participants) | Intervention |
|---|
| Catheter related blood stream infection rate(infections per 1000 catheter days) | Intervention |
|---|---|
| Median | 3.0 (0 to 12) |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2022 to primary completion in Mar 2025, 27 months.
Results were first posted in May 2026, 1 year 2 months after primary completion.
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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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