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

NCT04756427 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IRB00264457
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pediatric; home parenteral nutrition; intestinal failure

Outcome Measures

Primary Outcomes (1)

• Central Line-associated Bloodstream Infection (CLABSI) Rate

  Frequency of fever with positive central line blood culture events per central line days.

  12 months

Secondary Outcomes (3)

• Central Venous Catheter Thrombus Rate

  12 months

• Central Line Removal Rate

  12 months

• Number of Serious Adverse Events

  12 months

Study Arms (1)

Sodium citrate 4%

EXPERIMENTAL

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

Interventions

Sodium Citrate 4% Inj Syringe 3Ml DRUG

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instilled into the central catheter daily during the period that parenteral nutrition is not infusing, and will be withdrawn and disposed of prior to resuming infusion of parenteral nutrition

Also known as: ANDA BA125608 / Sodium Citrate 4% w/v Anticoagulant Solution USP

Sodium citrate 4%

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21131, United States

Location

Related Publications (7)

• Passero BA, Zappone P, Lee HE, Novak C, Maceira EL, Naber M. Citrate versus heparin for apheresis catheter locks: an efficacy analysis. J Clin Apher. 2015 Feb;30(1):22-7. doi: 10.1002/jca.21346. Epub 2014 Aug 13.

  PMID: 25132635 BACKGROUND

• Grudzinski L, Quinan P, Kwok S, Pierratos A. Sodium citrate 4% locking solution for central venous dialysis catheters--an effective, more cost-efficient alternative to heparin. Nephrol Dial Transplant. 2007 Feb;22(2):471-6. doi: 10.1093/ndt/gfl606. Epub 2006 Oct 25.

  PMID: 17065193 BACKGROUND

• Pittiruti M, Bertoglio S, Scoppettuolo G, Biffi R, Lamperti M, Dal Molin A, Panocchia N, Petrosillo N, Venditti M, Rigo C, DeLutio E. Evidence-based criteria for the choice and the clinical use of the most appropriate lock solutions for central venous catheters (excluding dialysis catheters): a GAVeCeLT consensus. J Vasc Access. 2016 Nov 2;17(6):453-464. doi: 10.5301/jva.5000576. Epub 2016 Aug 1.

  PMID: 27516141 BACKGROUND

• Weijmer MC, Debets-Ossenkopp YJ, Van De Vondervoort FJ, ter Wee PM. Superior antimicrobial activity of trisodium citrate over heparin for catheter locking. Nephrol Dial Transplant. 2002 Dec;17(12):2189-95. doi: 10.1093/ndt/17.12.2189.

  PMID: 12454232 BACKGROUND

• Michaud D, Komant T, Pfefferle P. Four percent trisodium citrate as an alternative anticoagulant for maintaining patency of central venous hemodialysis catheters: case report and discussion. Am J Crit Care. 2001 Sep;10(5):351-4. No abstract available.

  PMID: 11548568 BACKGROUND

• Battistella M, Vercaigne LM, Cote D, Lok CE. Antibiotic lock: in vitro stability of gentamicin and sodium citrate stored in dialysis catheters at 37 degrees C. Hemodial Int. 2010 Jul;14(3):322-6. doi: 10.1111/j.1542-4758.2010.00440.x. Epub 2009 Mar 24.

  PMID: 20345391 BACKGROUND

• Grudzinski A, Agarwal A, Bhatnagar N, Nesrallah G. Benefits and harms of citrate locking solutions for hemodialysis catheters: a systematic review and meta-analysis. Can J Kidney Health Dis. 2015 Apr 2;2:13. doi: 10.1186/s40697-015-0040-2. eCollection 2015.

  PMID: 25926995 BACKGROUND

MeSH Terms

Conditions

Intestinal Failure

Interventions

Sodium Citrate

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Darla Shores
• Organization: Washington University

shores@wustl.edu

314-454-6173

Study Officials

• Darla Shores, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort after intervention.

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 16, 2021
• Study Start: March 28, 2022
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)