Overview

Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD

Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
All
Summary
The aim of this study is to assess the superiority of the new low sodium peritoneal dialysis (PD) solution PDsol 12 in comparison with a conventional, already marketed solution, Gambrosol trio 40, in the treatment of the hypertensive peritoneal dialysis patients with aim to decrease hypertension and to improve the sodium/water balance.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fresenius Medical Care Deutschland GmbH
Treatments:
Dialysis Solutions
Pharmaceutical Solutions
Criteria
Inclusion Criteria:

- Chronic renal failure

- Stable patients on PD treatment

- Treatment at the study site for at least three months

- Treated in a CAPD program with a minimum of 3 bag exchanges with 6 or 7 days per week
including at least one with duration of 4-6 hours, and at least one low strength bag
per day, or in an APD program with at least one daytime exchange with duration of 4-6
hours using one low strength bag

- Hypertensive patients with high blood pressure at inclusion visit (Office SBP ≥ 140
and/or DBP ≥ 90 mmHg) or hypertensive patients receiving anti hypertensive medication
including diuretics, disregarded blood pressure values

- Patients aged 18 years or more

- Written consent to participate in the study (informed consent)

- Able to use a three-compartment bag

- Life expectancy and expected technical survival ≥ 9 months

Exclusion Criteria:

- Low blood pressure (Office sitting SBP ≤ 120 mmHg and confirmed by ABPM < or = to 105
mean 24h SBP)

- Orthostatic hypotension defined as Systolic OBP with a drop of > 20mmHg and
symptomatic after standing for at least 1 minute

- Natremia < 130 mmol/l, after two consecutive measurements

- Chronic arrhythmia

- Pregnancy or lactation

- Participation in other studies during the study period which may affect the outcome of
the present study

- Peritonitis within one month prior to the study start

- Exit site and /or tunnel infection

- Patients unable to tolerate 2 L bag exchanges

- Patients on non-compatible PD system