Last reviewed · How we verify

NCT04756427

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

Terminated Phase 4 Results posted Last updated 19 September 2024
What this trial tests

Phase 4 trial testing Sodium Citrate 4% Inj Syringe 3Ml in CLABSI - Central Line Associated Bloodstream Infection in 1 participant. Terminated before completion.

Timeline
28 March 2022
Primary endpoint
28 November 2023
28 November 2023

Quick facts

Lead sponsorJohns Hopkins University
PhasePhase 4
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment1
Start date28 March 2022
Primary completion28 November 2023
Estimated completion28 November 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Johns Hopkins University

Who can join

Under 18, any sex, with CLABSI - Central Line Associated Bloodstream Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for CLABSI - Central Line Associated Bloodstream Infection

Currently open trials in the same condition.

Other Johns Hopkins University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04756427.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing