NCT05813535

8.4% Sodium Bicarbonate Locks in Intestinal Failure

Sodium Bicarb Locks in Intestinal Failure

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Riad Rahhal · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intestinal Failure
• CRBSI - Catheter Related Bloodstream Infection

Interventions

Type	Name	Description
DRUG	Sodium bicarb lock	8.4% sodium bicarb locks when off venous nutrition

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-01-01
• Completion: 2024-12-01
• First posted: 2023-04-14
• Last updated: 2023-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study