8.4% Sodium Bicarbonate Locks in Intestinal Failure

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.

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Key information

Conditions

Intestinal Failure CRBSI - Catheter Related Bloodstream Infection Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Sodium bicarb lock

Drug

8.4% sodium bicarb locks when off venous nutrition

Primary outcomes

Rate of Catheter Related Bloodstream Infections

Time frame: Through study completion, an average of 1 year

Number of infections per 1000 catheter days

Sponsors and collaborators

Lead sponsor

Riad Rahhal

Other

Registry information

Official study title

Sodium Bicarb Locks in Intestinal Failure

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2025
First posted: Apr 14, 2023
Registry last updated: May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed