Clinical evaluation of a new low sodium peritoneal dialysis solution on patients with hypertensio
- Conditions
- Subjects with renal failure treated with peritoneal dialysisMedDRA version: 17.0Level: LLTClassification code 10009119Term: Chronic renal failureSystem Organ Class: 100000004857Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2007-005365-35-SE
- Lead Sponsor
- Fresenius Medical Care Deutschland GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 140
- Chronic renal failure
- Stable patients on CAPD with a minimum of 3 bag exchanges including at least one 4-6 hour dwell or patients on APD with at least one daytime exchange lasting for at least 4-6 hours
- Hypertensive patients with high blood pressure at inclusion (Office SBP =140 mmHg and/or DBP =90 mmHg) or hypertensive patients receiving antihypertensive medication, including diuretics, disregarding blood pressure values.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
- Low blood pressure (Office sitting SBP =120 mmHg and confirmed by ABPM =105 mmHg mean SBP)
- Ortostatic hypotension defined as systolic OBP with a drop of >20 mmHg and symptomatic after 1 minute in standing position
- Natremia <130 mmol/l, after two consecutive measurements
- Peritonits within one month prior to study start
- Exite site and/or tunnel infection
- (Patients unable to tolerate 2 L bag exchanges - Cancelled according to
amendment 1, dated 04.06.2012 on version 6.0, dated 17.02.2011)
- Patients with chronic arrhythmia
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method