Using sodium bicarbonate locks to prevent infections in children with intestinal failure
Sodium Bicarb Locks in Intestinal Failure
PHASE2 · University of Iowa · NCT05813535
This study is testing if using a sodium bicarbonate solution in catheters can help prevent infections in children who need these catheters for nutritional support due to intestinal failure.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | University of Iowa (other) |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT05813535 on ClinicalTrials.gov |
What this trial studies
This study focuses on children with intestinal failure who require central venous catheters for nutritional support. It aims to evaluate the effectiveness of using an 8.4% sodium bicarbonate solution as a catheter lock to reduce the risk of catheter-related bloodstream infections. Participants will have the sodium bicarbonate lock applied daily when the catheter is not in use, and it will be removed when the catheter is needed for nutrition or hydration. The study will monitor the incidence of infections in these patients over the course of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 18 years old with intestinal failure who have a central venous catheter and a history of catheter-related bloodstream infections.
Not a fit: Patients who do not have a central venous catheter or those without a history of catheter-related bloodstream infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of infections in children with intestinal failure who rely on central venous catheters.
How similar studies have performed: While the use of sodium bicarbonate locks is a novel approach, similar studies have shown promise in reducing infection rates with other catheter lock solutions.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Iowa City, Iowa
- University of Iowa — Iowa City, Iowa, United States (RECRUITING)
Study contacts
- Study coordinator: Riad Rahhal, MD
- Email: riad-rahhal@uiowa.edu
- Phone: +1 319 356 2950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Intestinal Failure, CRBSI - Catheter Related Bloodstream Infection