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

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be instilled into the central catheter daily during the period that parenteral nutrition is not infusing, and will be withdrawn and disposed of prior to resuming infusion of parenteral nutrition.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

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

Conditions
-----------------
CLABSI - Central Line Associated Bloodstream Infection

Intervention / Treatment
-----------------
* Drug: Sodium Citrate 4% Inj Syringe 3Ml


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective cohort after intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium citrate 4%<br>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<br>* 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<br>* Other names: ANDA BA125608 / Sodium Citrate 4% w/v Anticoagulant Solution USP;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 12 months | 
| Number of serious adverse events | Serious adverse events will be assessed with number of hospitalizations for any reason. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
home parenteral nutrition, pediatric, intestinal failure