8.4% Sodium Bicarbonate Locks in Intestinal Failure

NCT05813535 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 202205087
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intestinal Failure; CRBSI - Catheter Related Bloodstream Infection

Outcome Measures

Primary Outcomes (1)

• Rate of Catheter Related Bloodstream Infections

  Number of infections per 1000 catheter days

  Through study completion, an average of 1 year

Study Arms (1)

Baseline

OTHER

Patient on heparin locks when off venous nutrition

Drug: Sodium bicarb lock

Interventions

Sodium bicarb lock DRUG

8.4% sodium bicarb locks when off venous nutrition

Baseline

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

Sponsors & Collaborators

• Riad Rahhal: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Intestinal Failure

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Riad Rahhal
• Organization: Univ. of Illinois College of Medicine-Peoria

rrahhal@uic.edu

3096244535

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 14, 2023
• Study Start: December 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 28, 2026
• Results First Posted: May 28, 2026

Record last verified: 2026-05

Locations

US (1)