Status:
COMPLETED
Clinical Evaluation of Low Sodium Peritoneal Dialysis (PD) Solution on Hypertensive Patients Treated With PD
Lead Sponsor:
Fresenius Medical Care Deutschland GmbH
Conditions:
Chronic Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Hypertension as well as sodium and water retention are common in end-stage renal disease patients on peritoneal dialysis and expose patients to left ventricular hypertrophy and increase cardiovascular...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00794326
Start Date
October 1 2008
End Date
December 1 2014
Last Update
February 27 2015
Active Locations (29)
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1
Rigshospitalet
Copenhagen, Denmark
2
CHU Saint-Jacques
Besançon, France, 25000
3
CHRU
Caen, France, 14033
4
Hospital of Chambéry
Chambéry, France