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

Primary Purpose

CLABSI - Central Line Associated Bloodstream Infection

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sodium Citrate 4% Inj Syringe 3Ml
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for CLABSI - Central Line Associated Bloodstream Infection focused on measuring pediatric, home parenteral nutrition, intestinal failure

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Johns HopkinsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sodium citrate 4%

Arm Description

All enrolled participants will received the daily sodium citrate 4% locking solution for CLABSI prophylaxis intervention and be observed prospectively for adverse events

Outcomes

Primary Outcome Measures

Central line-associated bloodstream infection (CLABSI) rate
Frequency of fever with positive central line blood culture events per central line days.

Secondary Outcome Measures

Central venous catheter thrombus rate
Central line thrombus events requiring anti-coagulation treatment per central line days.
Central line removal rate
Central line removal events (infection or other dysfunction) per central line days.
Number of serious adverse events
Serious adverse events will be assessed with number of hospitalizations for any reason.

Full Information

First Posted
February 11, 2021
Last Updated
April 11, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT04756427
Brief Title
Sodium Citrate 4% Locking Solution for Children Requiring Home Parenteral Nutrition
Official Title
Sodium Citrate 4% Locking Solution for Children Requiring Home Parenteral Nutrition
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CLABSI - Central Line Associated Bloodstream Infection
Keywords
pediatric, home parenteral nutrition, intestinal failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Prospective cohort after intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sodium citrate 4%
Arm Type
Experimental
Arm Description
All enrolled participants will received the daily sodium citrate 4% locking solution for CLABSI prophylaxis intervention and be observed prospectively for adverse events
Intervention Type
Drug
Intervention Name(s)
Sodium Citrate 4% Inj Syringe 3Ml
Other Intervention Name(s)
ANDA BA125608 / Sodium Citrate 4% w/v Anticoagulant Solution USP
Intervention Description
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
Primary Outcome Measure Information:
Title
Central line-associated bloodstream infection (CLABSI) rate
Description
Frequency of fever with positive central line blood culture events per central line days.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Central venous catheter thrombus rate
Description
Central line thrombus events requiring anti-coagulation treatment per central line days.
Time Frame
12 months
Title
Central line removal rate
Description
Central line removal events (infection or other dysfunction) per central line days.
Time Frame
12 months
Title
Number of serious adverse events
Description
Serious adverse events will be assessed with number of hospitalizations for any reason.
Time Frame
12 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Darla Shores, MD
Phone
410-955-8769
Email
dshores1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darla Shores, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darla Shores, MD
Phone
410-955-8769
Email
dshores1@jhmi.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
de-identified data (demographics, outcomes) may be shared upon request
Citations:
PubMed Identifier
25132635
Citation
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.
Results Reference
background
PubMed Identifier
17065193
Citation
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.
Results Reference
background
PubMed Identifier
27516141
Citation
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.
Results Reference
background
PubMed Identifier
12454232
Citation
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.
Results Reference
background
PubMed Identifier
11548568
Citation
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.
Results Reference
background
PubMed Identifier
20345391
Citation
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.
Results Reference
background
PubMed Identifier
25926995
Citation
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.
Results Reference
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Sodium Citrate 4% Locking Solution for Children Requiring Home Parenteral Nutrition

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