CLABSI - Central Line Associated Bloodstream InfectionPhase 4NCT04756427
Sodium Citrate 4% Locking Solution for Children Requiring Home Parenteral Nutrition
A Phase 4 study testing Sodium Citrate 4% Inj Syringe 3Ml in people with CLABSI - Central Line Associated Bloodstream Infection, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- CLABSI - Central Line Associated Bloodstream Infection
- What is being tested?
- Sodium Citrate 4% Inj Syringe 3Ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2022to 28 Nov 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- known cardiac arrhythmias
- hypersensitivity to citrate
- pregnancy
- receiving continuous parenteral nutrition (infusing over 24 hours)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Sodium Citrate 4% Inj Syringe 3Ml
- Keywords
- pediatric, home parenteral nutrition, intestinal failure
- Medical subject headings
- Intestinal Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Citrate 4% Inj Syringe 3MlDrug
Also called ANDA BA125608 / Sodium Citrate 4% w/v Anticoagulant Solution USP
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Sodium Citrate 4% Inj Syringe 3Ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Line-associated Bloodstream Infection (CLABSI) Rate
Frequency of fever with positive central line blood culture events per central line days.
Measured: 12 months
Secondary outcomes (3)
Central Venous Catheter Thrombus Rate
Central line thrombus events requiring anti-coagulation treatment per central line days.
Measured: 12 months
Central Line Removal Rate
Central line removal events (infection or other dysfunction) per central line days.
Measured: 12 months
Number of Serious Adverse Events
Serious adverse events will be assessed with number of hospitalizations for any reason.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start28 Mar 2022
- Primary completion28 Nov 2023
- Study completion28 Nov 2023
Why it stopped: Subject recruitment was challenging
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CLABSI - Central Line Associated Bloodstream InfectionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort after intervention.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Darla Shores, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756427
- Sponsor's protocol ID
- IRB00264457
- Status last verified
- Sep 2024
- First submitted
- 11 Feb 2021
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: de-identified data (demographics, outcomes) may be shared upon request
Publications
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.
PubMed 25132635Grudzinski 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.
PubMed 17065193Pittiruti 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.
PubMed 27516141Weijmer 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.
PubMed 12454232Michaud 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.
PubMed 11548568Battistella 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.
PubMed 20345391Grudzinski 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.
PubMed 25926995
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Citrate 4% Locking Solution for Children Requiring Home Parenteral Nutrition
- ClinicalTrials.gov ID
- NCT04756427
- Acronym / sponsor ID
- IRB00264457
- Keywords
- pediatric, home parenteral nutrition, intestinal failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Subject recruitment was challenging
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Posted 4 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort after intervention.
| Arm | Type | Receives |
|---|---|---|
| Sodium citrate 4% | Experimental | Drug: Sodium Citrate 4% Inj Syringe 3MlAll enrolled participants will received the daily sodium citrate 4% locking solution for CLABSI prophylaxis intervention and be observed prospectively for adverse events |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- known cardiac arrhythmias
- hypersensitivity to citrate
- pregnancy
- receiving continuous parenteral nutrition (infusing over 24 hours)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Citrate 4% Inj Syringe 3MlAlso: ANDA BA125608 / Sodium Citrate 4% w/v Anticoagulant Solution USP3 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 | Drug | Sodium citrate 4% |
Primary outcome
Central Line-associated Bloodstream Infection (CLABSI) Rate
Time frame: 12 months
Frequency of fever with positive central line blood culture events per central line days.
3 secondary outcomes
Central Venous Catheter Thrombus Rate
Time frame: 12 months
Central Line Removal Rate
Time frame: 12 months
Number of Serious Adverse Events
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25132635Passero 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.
- Background: PubMed 17065193Grudzinski 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.
- Background: PubMed 27516141Pittiruti 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.
- Background: PubMed 12454232Weijmer 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.
- Background: PubMed 11548568Michaud 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.
- Background: PubMed 20345391Battistella 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.
- Background: PubMed 25926995Grudzinski 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.
- Individual participant dataSharing planned: No. de-identified data (demographics, outcomes) may be shared upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darla Shores, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium Citrate 4% Inj Syringe 3Ml in people with CLABSI - Central Line Associated Bloodstream Infection, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Line-associated Bloodstream Infection (CLABSI) Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04756427, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 4 Nov 2026.