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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.
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be instilled into the central catheter daily during the period that parenteral nutrition is not infusing, and will be withdrawn and disposed of prior to resuming infusion of parenteral nutrition.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Central Line-associated Bloodstream Infection (CLABSI) Rate | Frequency of fever with positive central line blood culture events per central line days. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Central Venous Catheter Thrombus Rate | Central line thrombus events requiring anti-coagulation treatment per central line days. | 12 months |
| Central Line Removal Rate | Central line removal events (infection or other dysfunction) per central line days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darla Shores, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins | Baltimore | Maryland | 21131 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25132635 | Background | 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. | |
| 17065193 | 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. |
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de-identified data (demographics, outcomes) may be shared upon request
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Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Central Line-associated Bloodstream Infection (CLABSI) Rate | Frequency of fever with positive central line blood culture events per central line days. | Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | 12 months |
|
Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Darla Shores | Washington University | 314-454-6173 | shores@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 25, 2022 | Aug 8, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000090124 | Intestinal Failure |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000077559 | Sodium Citrate |
| ID | Term |
|---|---|
| D019343 | Citric Acid |
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
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Prospective cohort after intervention.
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|
| 12 months |
| Number of Serious Adverse Events | Serious adverse events will be assessed with number of hospitalizations for any reason. | 12 months |
| 27516141 | 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. |
| 12454232 | 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. |
| 11548568 | 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. |
| 20345391 | 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. |
| 25926995 | 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. |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | Central Venous Catheter Thrombus Rate | Central line thrombus events requiring anti-coagulation treatment per central line days. | Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | 12 months |
|
|
| Secondary | Central Line Removal Rate | Central line removal events (infection or other dysfunction) per central line days. | Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | 12 months |
|
|
| Secondary | Number of Serious Adverse Events | Serious adverse events will be assessed with number of hospitalizations for any reason. | Only 1 participant was enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | Posted | 12 months |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |