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

NCT04756427 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-09-19

Study results available
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Summary

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.

Conditions

  • CLABSI - Central Line Associated Bloodstream Infection

Interventions

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instilled into the central catheter daily during the period that parenteral nutrition is not infusing, and will be withdrawn and disposed of prior to resuming infusion of parenteral nutrition

Sponsors & Collaborators

Principal Investigators

  • Darla Shores, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-28
Primary Completion
2023-11-28
Completion
2023-11-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04756427 on ClinicalTrials.gov