Peritoneal Ultrafiltration in Cardio Renal Syndrome.

Korábbi kezelés

• Acute coronary syndrome ≤ 6 months before;
• Cardiosurgical or Endo-radiological heart procedures ≤ 6 months before
• Cardiac resynchronization therapy (CRT) implantation or upgrading of pacemaker (PM) or implantable cardioverter defibrillator (ICD) to CRT ≤ 6 months before;
• Any major organ transplant (liver, lung, kidney)
• Lung embolism ≤ 6 months before;

Más betegség

• Recipients of heart transplantation
• Uncontrolled hypertension with systolic blood pressure ≥ 160 mmHg
• Fibrotic lung disease;
• Active malignancy;
• Evidence of any condition that, according to the investigators' judgment, could expose the subject to undue risk and/or prevent the subject from participating in the study procedures and/or potentially afftecting the study quality data.

Laborértékek

• Patient with end-stage renal disease, GFR urea clearance + creatinine clearance/2 (\<15 ml/min/1,73 m2 GFR)

Életkor

• Female patients of childbearing age who do not use adequate contracteption.

Egyéb

• Presence of a mechanical circulatory support device;
• Hypertrophic obstructive cardiomyopathy;
• Severe valvular stenosis;
• Restrictive cardiomyopathy;
• Active myocarditis
• Liver Cirrhosis;
• Absolute contraindication to peritoneal catheter implantation;
• Logistical and or organizational contra-indication to treatment
• Female patients who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical trial and for three months later
• Unwilling and unable to give informed consent;
• Enrolment in another clinical trial involving medical or device based interventions.
• Hypersensibility to IMP components.

• Age ≥18 yrs
• Left ventricular ejection fraction ≤60%
• NYHA Classification of III-IV despite guidelines directed medical therapy
• Right ventricular failure due to after load mismatch, addressed by the presence of tricuspid calve regurgitation (≥ moderate) and by the disproportioned increase of the right atrial pressure (RAP) versus the capillary wedge pressure (CWP) with a ratio ≥0.65, detected with right heart catheterization performed after stable medical therapy according to international guidelines and comprehensive of loop diuretic (equivalent to furosemide oral dose till 2.0 mg/kg/day), coupled with urinary sodium excretion ≤ mEq/L, confirmatory of loop diuretic resistance.
• Cava vein enlargement (inner diameter, detected with focused echocardiography, between 1,5 and 2,5 cm, with respiratory collapse \<50% or absent due to intravascular fluid overload)
• Decreased kidney function addressed by the measurement of glomerular filtration rate (GFR) urea clearance + creatinine clearance/2 (\>15 ml/min/1,73 m2)
• NT pro-BNP plasma concentration \> 1000 pg/ml or BNP plasma concentration \> 250 pg/ml
• at least one episode of pulmonary or systemic congestion requiring high-dose intravenous diuretics (or diuretic combinations) in the 6 months befor the study enrollment
• An appropriate PUF technique candidate.
• Signed informed consent