8.4% Sodium Bicarbonate Locks in Intestinal Failure

Intestinal Failure Clinical Trial

Official title:

Sodium Bicarb Locks in Intestinal Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05813535
• Other study ID #: 202205087
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: University of Iowa
• Contact: Riad Rahhal, MD
• Phone: +1 319 356 2950
• Email: riad-rahhal[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Intestinal Failure
• Sepsis

Intervention

Drug:
• Sodium bicarb lock
8.4% sodium bicarb locks when off venous nutrition

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Riad Rahhal

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of catheter related bloodstream infections	Number of infections per 1000 catheter days	Through study completion, an average of 1 year