Sodium Citrate 4% Locking Solution for Children Requiring Home Parenteral Nutrition

September 3, 2024 updated by: Johns Hopkins University
This study an open label prospective observational cohort study to evaluate the safety and efficacy of sodium citrate 4% locking solution in preventing central line associated blood stream infection in children requiring long term central venous catheters for home parenteral nutrition. Sodium citrate 4% is FDA-approved for dialysis catheters, but has not been formally evaluated for use in tunneled catheters for parenteral nutrition. The rate of central line-associated bloodstream infection (CLABSI) and other potential adverse events will be monitored for 12 months, with the option to remain in the study for a longer period of time.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

In this prospective observational cohort study of pediatric patients requiring home parenteral nutrition for intestinal failure, participants will be enrolled from the pediatric intestinal rehabilitation clinic, and data collection will be obtained from the electronic medical record. Participant will receive daily sodium citrate 4% catheter locking solution for CLABSI prophylaxis, instead of heparin locks. Participants will be monitored for 12 months for adverse events, including CLABSI. Participants will have the same routine laboratory schedule and monthly outpatient follow up. After 12 months, participants will be given the option to continue to use sodium citrate 4% locks after the initial study period if no serious adverse events have occurred. The investigators anticipate enrolling 10-15 participants per year and anticipate enrollment to continue for 3-5 years.

Sodium citrate locks: 3 ml vials of locking solution will be prepared by the infusion pharmacy using commercially available 4% sodium citrate IV fluid (available in 500 ml bags). The sodium citrate locks will be instilled into the central catheter daily during the period that parenteral nutrition is not infusing, and will be withdrawn and disposed of prior to resuming infusion of parenteral nutrition. If subjects are hospitalized, sodium citrate locks will be temporarily held during the duration of the inpatient stay, and will be resumed once the participant is discharged home.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21131
        • Johns Hopkins

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pediatric patients (<18 years) and adult patients (up to 21 years still in our clinic)
  • requiring long-term (>3 months) home parenteral nutrition due to intestinal failure/short bowel syndrome
  • has had at least one central line-associated blood stream infection

Exclusion Criteria:

  • known cardiac arrhythmias
  • hypersensitivity to citrate
  • pregnancy
  • receiving continuous parenteral nutrition (infusing over 24 hours)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sodium citrate 4%
All enrolled participants will received the daily sodium citrate 4% locking solution for CLABSI prophylaxis intervention and be observed prospectively for adverse events
Drug: Sodium Citrate 4% Inj Syringe 3Ml
3 ml of sodium citrate 4% locking solution instilled into the central catheter daily during the period that parenteral nutrition is not infusing, and will be withdrawn and disposed of prior to resuming infusion of parenteral nutrition
Other Names:
  • ANDA BA125608 / Sodium Citrate 4% w/v Anticoagulant Solution USP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central Line-associated Bloodstream Infection (CLABSI) Rate
Time Frame: 12 months
Frequency of fever with positive central line blood culture events per central line days.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central Venous Catheter Thrombus Rate
Time Frame: 12 months
Central line thrombus events requiring anti-coagulation treatment per central line days.
12 months
Central Line Removal Rate
Time Frame: 12 months
Central line removal events (infection or other dysfunction) per central line days.
12 months
Number of Serious Adverse Events
Time Frame: 12 months
Serious adverse events will be assessed with number of hospitalizations for any reason.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Darla Shores, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Actual)

November 28, 2023

Study Completion (Actual)

November 28, 2023

Study Registration Dates

First Submitted

February 11, 2021

First Submitted That Met QC Criteria

February 11, 2021

First Posted (Actual)

February 16, 2021

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 3, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00264457

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

de-identified data (demographics, outcomes) may be shared upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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