8.4% Sodium Bicarbonate Locks in Intestinal Failure

Riad Rahhal

Status and phase

Enrolling

Phase 2

Conditions

Intestinal Failure

CRBSI - Catheter Related Bloodstream Infection

Treatments

Drug: Sodium bicarb lock

Study type

Interventional

Funder types

Other

Identifiers

NCT05813535

202205087

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion and 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)