Kidney Week

Abstract: SA-PO944

A Novel Device Allows Simplicity and Independence to Peritoneal Dialysis (PD) Patients

Session Information

• Peritoneal Dialysis: Inflammation, Peritoneal Transport
  November 09, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Dialysis

• 703 Dialysis: Peritoneal Dialysis

Authors

• Tanasiychuk, Tatiana, Carmel Medical Center, Haifa, Israel

Tatiana Tanasiychuk,

• Kushnir, Daniel, Carmel Medical Center, Haifa, Israel

Daniel Kushnir,

• Antebi, Alon, Carmel Medical Center, Haifa, Israel

Alon Antebi,

• Marcuson, Jerom, Carmel Medical Center, Haifa, Israel

Jerom Marcuson,

• Gil, Amnon, Carmel Medical Center, Haifa, Israel

Amnon Gil,

• Sura, Oleg, Carmel Medical Center, Haifa, Israel

Oleg Sura,

• Frajewicki, Victor, Carmel Medical Center, Haifa, Israel

Victor Frajewicki,

• Benchetrit, Sydney, Meir Medical Center, Kfar Saba, Center, Israel

Sydney Benchetrit,

• Einbinder, Yael, Meir Medical Center, Kfar Saba, Center, Israel

Yael Einbinder,

Background

Although peritoneal dialysi is considered a simple method of renal replacement therapy accesible to almost every one, it is still underutilized worldwide. The barriers could be difficulties in fine motor skills, decreased vision, insecurity of performing a precise method alone, time consumption and more. liberDi's portable PD system (PPDS^TM) is a newly developed small automatic device intended for PD exchange. It uses a small electric battery operated pump for inflow/outflow mechanism to drain and fill the dialysate at a controllable rate. The device makes the exchange after automatic disinfection of the connectors. The PPDS^TM also enables monitoring of effluent dialysate (stream flow, fluid clarity, temperature) and transmits the data to the PD center.
This first-in-human open single arm, multicenter clinical trial was performed in 2 different PD units- Carmel Medical Center and Meir Medical Center in Israel. The goal of the study was to verify safety of the liberDi's PPDS^TM as primary endpoint toward evaluating its usability and feasibility.

Methods

The trial includes 10 stable chronic adult CAPD patients, treated more than 3 months, used to do at least 3 exchanges daily. During the trial a single exchange was performed in the PD clinic via the liberDi's PPDS^TM under supervision of the PD team, followed by a one-month clinical follow-up.

Results

Average drainage time was 10.7±2.3 min, filling time 8±2.6 min. Three patients noted mild abdominal discomfort at the end of the draining and start of filling (not unusual for them), while one patient showed slow drainage and shifted to a regular manual exchange. None of the patients developed peritonitis during the follow- up period. One patient died due to acute ST elevation myocardial infarction 5 days after the trial procedure, which was considered as unrelated to the procedure itself.

Conclusion

This first-in-human study showed the safety of liberDi's PPDS device demostrating its feasibility in a single automatic PD exchange. Its use seems to be convenient, easy and safe.

Funding

• Commercial Support – liberDi