CLABSI - Central Line Associated Bloodstream Infection
Conditions
Keywords
pediatric, home parenteral nutrition, intestinal failure
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be instilled into the central catheter daily during the period that parenteral nutrition is not infusing, and will be withdrawn and disposed of prior to resuming infusion of parenteral nutrition.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.
Interventions
DRUGSodium 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instilled into the central catheter daily during the period that parenteral nutrition is not infusing, and will be withdrawn and disposed of prior to resuming infusion of parenteral nutrition
Sponsors
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Prospective cohort after intervention.
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central Line-associated Bloodstream Infection (CLABSI) Rate | 12 months | Frequency of fever with positive central line blood culture events per central line days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central Venous Catheter Thrombus Rate | 12 months | Central line thrombus events requiring anti-coagulation treatment per central line days. |
| Central Line Removal Rate | 12 months | Central line removal events (infection or other dysfunction) per central line days. |
| Number of Serious Adverse Events | 12 months | Serious adverse events will be assessed with number of hospitalizations for any reason. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Central Line-associated Bloodstream Infection (CLABSI) Rate
Frequency of fever with positive central line blood culture events per central line days.
Time frame: 12 months
Population: 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.
Secondary
Central Line Removal Rate
Central line removal events (infection or other dysfunction) per central line days.
Time frame: 12 months
Population: 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.
Secondary
Central Venous Catheter Thrombus Rate
Central line thrombus events requiring anti-coagulation treatment per central line days.
Time frame: 12 months
Population: 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.
Secondary
Number of Serious Adverse Events
Serious adverse events will be assessed with number of hospitalizations for any reason.
Time frame: 12 months
Population: 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.