Evaluation of low sodium PDF in hypertensive PD patients

• Research type

  Research Study

• Full title

  Multicenter, parallel, controlled, randomized, single-blind clinical evaluation of new low sodium peritoneal dialysis solution on patients with hypertension treated with continuous ambulatory or automated peritoneal dialysis

• IRAS ID

  96620

• Contact name

  Simon J Davies

• Sponsor organisation

  Fresenius Medical Care Deutschland GmbH

• Eudract number

  2007-005365-35

• Clinicaltrials.gov Identifier

  NCT00794326

• Research summary

  Salt and water retention is a major factor contributing to the development of high blood pressure in patients treated on chronic dialysis. Therefore, sodium (Na) balance anflud status should be better controlled. A new approach to facilitate the Na elimination by dialytic Na removal is to reduce the Na concentration in the Peritoneal Dialysiflud, thus increasing its diffusive elimination. To further investigate iflud with low sodium is an advantage for the patient a long term study is needed. During 6 months the neflud will be investigated. Patients who are stable on peritoneal dialysis therapy with high blood pressure are eligible for the study. Once a day a study bag replaces a usual bag exchange.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  12/NW/0180

• Date of REC Opinion

  30 May 2012

• REC opinion

  Further Information Favourable Opinion