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