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

NCT ID: NCT04756427

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-28
• Study Completion Date: 2023-11-28

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.

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be instilled into the central catheter daily during the period that parenteral nutrition is not infusing, and will be withdrawn and disposed of prior to resuming infusion of parenteral nutrition.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

Conditions

CLABSI - Central Line Associated Bloodstream Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Sodium Citrate 4% Inj Syringe 3Ml

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

ANDA BA125608 / Sodium Citrate 4% w/v Anticoagulant Solution USP

Eligibility Criteria

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)

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Darla Shores, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 25132635 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17065193 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27516141 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12454232 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11548568 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20345391 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25926995 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00264457

Identifier Type: -

Identifier Source: org_study_id