Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Trea… (NCT00794326) | Clinical Trial Compass
CompletedPhase 3
Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD
Denmark, France140 participantsStarted 2008-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
The primary criterion is the ambulatory 24 h mean systolic blood pressure measurement and drug doses management after 2 months of treatment compared to Baseline.
Timeframe: At the beginning and after 8 weeks of treatment