Sponsor study identifier
interventional
46
1 country
1
Study Start
June 15, 2023
Actual (reported)Primary Completion
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Biofilm formation is an important cause of catheter-related infection. In hemodialysis, use of an antibiotic-lock has been proven to be effective to manage such a complication with preservation of the central venous catheter. In peritoneal dialysis, while biofilm has been implicated in relapsing and repeat peritonitis, both of which are caused by the identical bacteria as in their preceding peritonitis episode, no adjunctive measure has been proven to be effective to eradicate the biofilm bacteria. As a result, Tenckhoff catheter removal is the only recommended option for the patients suffering from relapsing or repeat peritonitis. In this study, the investigators are going to investigate whether the use of an antibiotic-lock can be useful to eradicate the biofilm in the Tenckhoff catheter to prevent future episodes of peritonitis caused by the same organism.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 23, 2023
Actual (reported)June 15, 2023
Actual (reported)August 2, 2023
Actual (reported)October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
rate of developement of relapsing or repeat peritonitis
Development of relapsing peritonitis (within 4 weeks of completion of antibiotics) or repeat peritonitis (between 4 to 12 weeks of completion of antibiotics) again
6 month
rate of development of peritonitis due to same organism, beyond 12 weeks
6 month
in addition to the appropriate IP antibiotics, an antibiotic-lock will be prepared by the same antibiotics. We will follow the suggested data used in hemodialysis catheter for the concentration of different antibiotics to prepare the locking solution The resulting locking solution will be instilled precisely to fill up the Tenckhoff catheter and the transfer set once a day. Prior to that, the existing PD solution is drained out first. As such, a "dry abdomen" is maintained during antibiotic-lock dwelling in the Tenckhoff catheter. This is to ensure the antibiotic-lock solution can be maintained within the catheter lumen for a prolonged period of time After a 6-hour dwell, the antibiotic-lock is drained out and usual PD schedule is resumed. Such a daily application of antibiotic lock shall last until the course of IP antibiotics is completed.
In the control arm, appropriate IP antibiotics are to be continued. The dosage and duration of antibiotics will fully follow the recommendation from the latest International Society for Peritoneal Dialysis (ISPD) peritonitis guidelines \*For the subjects in the control arm who reach the defined primary end-point, they will automatically undergo crossover to the intervention arm to receive standard IP antibiotics together with the intra-catheter antibiotic-lock. They will be followed for another 6 months subsequently.
In the intervention arm, in addition to the appropriate IP antibiotics, an antibiotic-lock will be prepared by the same antibiotics. We will follow the suggested data used in hemodialysis catheter for the concentration of different antibiotics to prepare the locking solution . Some commonly used antibiotics for the treatment of PD peritonitis with their suggested concentrations in the antibiotic-lock are quoted as below: Cefazolin 10mg/mL Ceftazidime 10mg/mL Vancomycin 10mg/mL Gentamicin 5mg/mL Tienam 50mg/mL
Alice Ho Miu Ling Nethersole Hospital
Tai Po, Hong Kong
Li PK, Szeto CC, Piraino B, de Arteaga J, Fan S, Figueiredo AE, Fish DN, Goffin E, Kim YL, Salzer W, Struijk DG, Teitelbaum I, Johnson DW. ISPD Peritonitis Recommendations: 2016 Update on Prevention and Treatment. Perit Dial Int. 2016 Sep 10;36(5):481-508. doi: 10.3747/pdi.2016.00078. Epub 2016 Jun 9. No abstract available.
Justo JA, Bookstaver PB. Antibiotic lock therapy: review of technique and logistical challenges. Infect Drug Resist. 2014 Dec 12;7:343-63. doi: 10.2147/IDR.S51388. eCollection 2014.
ping kwan chan
Alice Ho Miu Ling Nethersole Hospital
First Submitted
May 23, 2023
First Posted
August 2, 2023
Study Start
June 15, 2023
Actual (reported)Primary Completion
October 2026
EstimatedNeutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold) Clinical Trial Protocol
In the control arm, appropriate IP antibiotics are to be continued. The dosage and duration of antibiotics will fully follow the recommendation from the latest International Society for Peritoneal Dialysis (ISPD) peritonitis guidelines
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Wong SS, Lau WY, Chan PK, Wan CK, Cheng YL. Extended Experience in the Use of Antibiotic Lock for Eradication of Biofilm Bacteria on Tenckhoff Catheter. Perit Dial Int. 2019 Mar-Apr;39(2):187-190. doi: 10.3747/pdi.2018.00098.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 31, 2024
Record last verified: 2024-01
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