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NCT04756427
Sodium Citrate 4% Locking Solution for Children Requiring Home Parenteral Nutrition
Phase 4 trial testing Sodium Citrate 4% Inj Syringe 3Ml in CLABSI - Central Line Associated Bloodstream Infection in 1 participant. Terminated before completion.
28 November 2023
Quick facts
| Lead sponsor | Johns Hopkins University |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 1 |
| Start date | 28 March 2022 |
| Primary completion | 28 November 2023 |
| Estimated completion | 28 November 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Sodium Citrate 4% Inj Syringe 3Ml — full drug profile →
Conditions studied
- CLABSI - Central Line Associated Bloodstream Infection — all drugs for CLABSI - Central Line Associated Bloodstream Infection →
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:
- PubMed search for NCT04756427
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Related trials
Other recruiting trials for CLABSI - Central Line Associated Bloodstream Infection
Currently open trials in the same condition.
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- NCT06085690 — Multicenter Clinical Translational Study of "ICU-NO CRBSI" Based on Improvement Science · NA · recruiting
Other Johns Hopkins University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04756427 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
- Last refreshed: 19 September 2024
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing