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APD

APD - man sitting on a bed

Automated peritoneal dialysis with sleep•safe harmony and SILENCIA

DISCLAIMER

Not all products and services are cleared or available for sale in all EU countries. Check your country web site for details. 

Why automated peritoneal dialysis (APD)?

APD uses a programmable machine, or cycler, that controls the volume, filling, dwell time and drainage of the solution. Thanks to automated dialysis, patients can be dialyzed at home, even when sleeping.

As APD is offering more free daytime, it is the PD technique with obvious advantages for patient’s lifestyle. Patients may pursue a job and have more time for personal and family activities.1

Finally, APD cyclers offer a variety of individualization options for the treatment, allowing you to even better consider the needs of your patient, supporting you to improve patient care.

In APD both our cyclers, sleep•safe harmony and SILENCIA, offer advanced features, all aimed at improving patient care.

  • Increased treatment flexibility with FlexPoint technology3
  • Integrated on-screen animations give guidance and facilitate setup3
  • As proposed by Fischbach et al., potentially improved ultrafiltration and clearance with individually adapted APD (aAPD)2

Getting started with education in APD – The difficult part was making it easier

FMC created training solutions that focus on conveying the information that really matter and offers support in preparing and setting up the treatment.

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Our products - Key features of the sleep·safe harmony

sleep·safe harmony offers features aimed at improving patient care. It also provides training support by guiding on-screen animations directly on the device.

  • Create prescriptions directly on the device
  • On-screen keyboard
  • Improved fluid usage – no extra volume for priming
  • Permitted patient volume – the maximum individual fill volume
  • Permitted residual volume – the maximum individual volume that may remain in the patient’s peritoneal cavity
     
  • The goal is to:
    • Reduce potential outflow alarms for a more quiet and restful sleep
    • Maintain the prescribed treatment time
    • Improve treatment effectiveness
    • Provide more flexibility in treatment execution within defined individual limits to improve patients’ well-being and safety
  • Automatic connection and barcode recognition of bags
  • Integrated handles
  • PatientCardplus capable of storing up to nine different prescriptions and more than 12 months of treatment data
  • Automatic inline flow heating of the dialysis solution to body temperature directly during the inflow phase -  no need to preheat the solution bag upfront/in advance of the treatment
  • Automatic draining feature – the solution bags and the line set are drained automatically, no manual handling needed
  • Plug & use – no transformer needed due to double installation
  • Guiding animations directly on the device
  • Large touch screen
  • sleep•safe harmony system daily disposables are made of PVC-free and plasticizer-free materials such as Biofine (Except APD drainage options)

Our products - Key features of SILENCIA

SILENCIA is delivering individual APD therapy in a reliable and convenient way, providing the following benefits :

  • Improved sleep quality due to silent operation and soft alarms4,5
  • Simple design enables easy setup and short training time6
  • APD individualization as supported by the latest ISPD guidelines7
  • Developed for home use even with limited space
  • High patient satisfaction with the handling of the SILENCIA cycler
  • Increased treatment flexibility with FlexPoint technology

Adapted APD (aAPD) is one way to personalize treatments

sleep•safe harmony and SILENCIA offer multiple options to individualize prescriptions according to patients' needs. Using our APD cyclersthe prescription can be individualized on several levels:

  • Infusion volume
  • Dwell time
  • Glucose profile
  • Calcium profile
  • FlexPoint


Different PD solutions per cycle within the same treatment can be used with sleep•safe harmony.

Because every patient is different: aAPD – Fischbach et al.2 suggests potential better results using the same time and resources2

Your patients have a chronic disease in common, but differ in many ways: age, height, weight, stage of illness, residual kidney function etc. These differences have a decision impact on the PD treatment required. 
Patients’ needs are different:

Age is an important factor influencing the choice of dialysis modality. Patients with good dexterity and motivation are good candidates for PD. With increasing age, the associated comorbidities of dialysis patients might deteriorate and with it their frailty.

Management of weight is an important success factor in PD patients. Changes in weight due to lifestyle, calorie intake, disease and hydration status need constant monitoring and adaptation of PD therapy.

Dialysate to plasma ratio is a common measure used to evaluate peritoneal transport characteristic in PD patients. Patients can be into high (fast), high average and low (slow) transporters based depending upon the status of their peritoneal membrane.  Peritoneal membrane transport characteristics change with time on PD. Therefore, regular monitoring of D/P creatinine and subsequent adjustment of PD prescriptions is recommended.

Patients are classified into high (fast), high average and low (slow) transporters based on the function of their peritoneal membrane. With time and increasing duration of stay on PD, patients tend to become fast transporters. PD prescriptions need to be adapted according to patients' transport status for an optimal patient outcome.

RKF has an impact on patient survival and quality of life of PD dialysis patients. Its longer preservation is a major advantage. Thus, interventions to preserve RKF, like prescription of biocompatible PD fluids, are important.

Due to compromised kidney function, bodies' own capacity to remove excess fluid also diminishes and patients need dialysis to generate UF. The amount of UF needed varies depending upon many factors, like lifestyle, disease progression and other comorbid conditions. An adequate UF is therefore critical for successful PD.

Kt/V urea is urea clearance normalized to total body water. It is an important parameter to check PD adequacy. A total Kt/V urea of at least 1.7 per week is recommended for PD patients.8

APD study

Fischbach study supports aAPD2

Fischbach M. et al. conducted a randomized, prospective, cross-over, multicenter study. Nineteen patients were included in the final analysis.

According to Fischbach et al., aAPD offers better results using the same time and resources2

  • aAPD is possible without extra fluids or a longer amount of time
  • Efficiently uses existing treatment resources: better ultrafiltration and clearance with same, low glucose concentration, fluid volume and treatment time compared to conventional APD (cAPD)

Attaining adequacy targets

The aAPD approach was proposed by Fischbach M. et al.2 By combining sequences of short dwells and small fill volumes with long dwells and large fill volumes, aAPD aims to promote UF and clearance within one PD session. The blood purification and UF achieved for every gram of glucose absorbed was higher in aAPD in comparison to cAPD.

The challenges of PD – Reaching adequacy targets

Reaching adequacy targets in PD for both UF and clearance is challenging. Fischbach et al. propose that shorter dwell times and smaller fill volumes promote the process of UF, while longer dwell times and large fill volumes increase solute clearance.2 The proposed strategy may have the potential to improve the two targets within one PD session.

cAPD

APD chart

Figure 1: Modified cAPD graphic following Fischbach M. et al.

aAPD

aAPD chart

Figure 2: Modified aAPD graphic following Fischbach M. et al.

Adapted APD is possible without extra fluids or a longer amount of time, with the same glucose concentration.

The study results suggest that, compared with cAPD, targeting UF vs. clearance separately, by varying dwell times and fill volumes may improve dialysis adequacy with a reduction in metabolic burden.2

Comparison after 45 days1

comparison after 45 days

Figure 3: Figure created based on study data from Fischbach, M. et al., comparing mean daily UF and sodium removal after 45 days, showing better UF (+100 mL/session) and sodium removal (+14 mmol/session) for aAPD

Higher clearance with aAPD

Figure 4: Figure created based on study data from Fischbach, M. et al,. Higher clearance with aAPD over glucose absorbed

Summary of potential patient benefits as reported by Fischbach et al2

Patient benefits

  • Improves ultrafiltration
  • Better sodium removal
  • Lower blood pressure
  • Promotes clearance: urea, creatinine, phosphate
  • Reduced metabolic load
     

Clinical value

  • Improved use of existing treatment resources: better ultrafiltration and clearance with same, low glucose concentration, fluid volume and treatment time compared to cAPD

APD monitoring and support

Smart digital tools offer convenience for patients and caregivers in the comfort of the patients’ homes.

* The service is not available in all countries. The availability of the service and products must be clarified before planning or booking a vacation.

DISCLAIMER

Not all products and services are cleared or available for sale in all EU countries. Check your country web site for details. 

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1 Roumeliotis A et al. Int Urol Nephrol 2021; 53(6):1149-1160

2 Fischbach M et al. Peritoneal Dial Int 2011; 31(4):450-458

3 Punzalan S et al. Journ of Kidn Care 2017; 2(5):262-267

4 Morales R et al. 2021 ISPD Congress, PO-40 (abstract, article submitted)

5 Unpublished data on file at Fresenius Medical Care DeutschlandGmbH; with operation noise of LAeq 12-14 dB classification as “silently operating” according to Berglund, Birgitta, Lindvall, Thomas, Schwela, Dietrich H & World Health Organization. Occupational and Environmental Health Team. (1999). Guidelines for community noise. World Health Organization, page 10, available as download under https://apps.who.int/iris/handle/10665/66217; site was accessed the last time 31/07/2023; 16:35 CET

6 Unpublished data on file at Fresenius Medical Care Deutschland GmbH (short training times)

7 Brown EA et al. Perit Dial Int. 2020;40(3):244-253.

8 Tzamaloukas AH et al. Semin Dial 2008; 21(3):250-257