The Effect of Balance PD Solution on the Peritoneal Membrane in Patients on Automated Peritoneal Dialysis

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the biocompatibility of the peritoneal dialysis (PD) solution balance in comparison to the conventional PD solution in APD(automated peritoneal dialysis) patients using the APD cycler sleep•safe.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fresenius Medical Care Deutschland GmbH
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• APD patient ≥ 18 years

• Prevalent patient with at least 3 months experience on APD prior to inclusion

• Patient is trained on and being treated with the sleep•safe APD cycler

• Patient treated on APD exclusively with registered conventional PD solutions CAPD 2, CAPD 3, CAPD 4, CAPD 17, CAPD 18 or CAPD 19 for at least 8 weeks prior to inclusion

• Patient is on stable diuretic treatment e.g no change in diuretic treatment within the last 30 days prior to inclusion

• Informed consent signed and dated by study patient and investigator/authorised physician

• Ability to understand the nature and requirements of the study

Exclusion Criteria:

• Peritonitis treatment £ 4 weeks preceding inclusion

• APD patients treated with IPD modality (intermittent peritoneal dialysis)

• Malignant disease without remission

• Patients with artificial joints, amputations, stents, or pacemaker

• Patients with congestive heart failure or coronary artery disease NYHA (New York Heart Association) III and higher

• Active HBV (hepatitis B virus)or HCV(hepatitis C virus)infection- HIV positive

• Participation in an interventional clinical study during the preceding 30 days

• Any condition which could interfere with the patient's ability to comply with the study