8.4% Sodium Bicarbonate Locks in Intestinal Failure

Sponsor

Riad Rahhal (Other)

Overall Status

Recruiting

CT.gov ID

NCT05813535

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intestinal Failure CRBSI - Catheter Related Bloodstream Infection	Drug: Sodium bicarb lock	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Sodium Bicarb Locks in Intestinal Failure

Actual Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Baseline Patient on heparin locks when off venous nutrition	Drug: Sodium bicarb lock 8.4% sodium bicarb locks when off venous nutrition

Arm

Intervention/Treatment

Other: Baseline

Patient on heparin locks when off venous nutrition

Drug: Sodium bicarb lock

8.4% sodium bicarb locks when off venous nutrition

Outcome Measures

Primary Outcome Measures

Rate of catheter related bloodstream infections [Through study completion, an average of 1 year]
Number of infections per 1000 catheter days

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa	Iowa City	Iowa	United States	52242

Sponsors and Collaborators

Riad Rahhal

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Riad Rahhal, Clinical Professor, University of Iowa

ClinicalTrials.gov Identifier:

NCT05813535

Other Study ID Numbers:

202205087

First Posted:

Apr 14, 2023

Last Update Posted:

Apr 14, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sepsis

Study Results

No Results Posted as of Apr 14, 2023