Early Feasibility Study to Evaluate the Safety and Efficacy of PAK HD in ESRD Patients

Korábbi kezelés

• Subjects with severe hypertension: systolic blood pressure > /=180 mmHg, diastolic blood pressure >/=120 mmHg in any officemeasurement less than 4 weeks prior to enrolment.
• Subjects with episodes of haemolysis in any measurement 3 months prior to enrolment.
• Subjects with vascular access dysfunction (whether or not requiring an intervention), i.e. failure to achieve and/ or sustain a bloodflow of >/=250 mL/min and/or signs of compromised vascular access patency (according to the opinion of the investigator) within 4weeks prior to enrolment.
• Subjects with vascular access related infection less than 4 weeks prior to enrolment
• Subjects who participated in another clinical intervention or device trial less than 12 weeks prior to enrolment, are currentlyparticipating or intend to participate in such a trial.
• Subjects who are anticipating a living donor kidney transplantation within < 2 months of the study period.
• Subjects with recent history of drug and/or alcohol abuse in the last 3 months prior to enrolment.

Más betegség

• Subjects with chronic obstructive pulmonary disease or any respiratory disease that may predispose to CO2 retention.

Laborértékek

• Subjects with haemoglobin level of <10.5g/dL in any measurement 2 months prior to enrolment.
• Subjects with the following pre-dialysis serum values in any measurement 2 months prior to enrolment:
  • sodium concentration <132 mmol/L or > 145mmol/L
  • bicarbonate <15mmol/L or >30mmol/L
  • plasma potassium concentration <3.5mmol/L or >5.8mmol/L
  • urea <15mmol/L or >28 mmol/L
• Subjects with impaired liver function. Impaired liver function is defined as an elevated ALT (alanine aminotransferase) by 3-fold orgreater above the upper limit of normal.

Egyéb

• Subjects with a central venous catheter.
• Subjects requiring an average ultrafiltration volume >2.8 L per 4-h treatment in mid-week dialysis session in the past 4 weeks priorto enrolment.
• Subjects who are on heparin free dialysis
• Subjects who are unable to provide informed consent.
• Subjects who are unable to comply with study procedures.
• Subjects with psychosocial problems which may negatively influence dialysis treatment.
• Subjects who are pregnant, breast feeding, or planning a pregnancy within the study period.
• Subjects with a life expectancy <1 year.

• Subjects must be adults >/= 21 years old and <80 years old.
• Subjects must be weighing >/= 55kg and <90kg (patient's dry weight).
• Subjects must have stable haemoglobin >/= 10.5g/dL, 2 months prior to enrolment
• Subjects' pre-dialysis serum values must be within the following range, 2 months prior to enrolment:
  • Patient allowable serum biochemistry ranges Allowable pre-dialysis serum values Na >/= 132 mmol/L or </= 145mmol/L HCO3 >/= 15mmol/L or </= 30mmol/L K >/= 3.5mmol/L or </= 5.8mmol/L
• Subjects on stable on thrice weekly 4-h HD schedule. Stability is defined as:
  • Haemodynamic stability during dialysis (absence of hypotensive events and symptomatic arrhythmias), no angina pectoris, AND
  • No altered level of consciousness during dialysis.
• Subjects with a well-functioning vascular access (native fistula graft):
  • capable of providing a blood flow rate of >/= 250 mL/min, AND
  • no vascular access revision and stable shunt flow for at least 4 weeks prior to enrolment.
• Subjects capable of understanding the informed consent form and give informed consent.
• Subjects willing and able to comply with study procedures and to attend all study follow-up visits.
• Subjects who are female of reproducible age to practice birth control methods.
• Subjects can be either gender.