A multicenter, prospective, randomised, cross-over, exploratory, open pilot study to evaluate the influence on METAbolomics and PROteomics in end stage renal disease patients with post-dilution On-LINE-HDF versus conventional haemodialysis - Metaprol-Study

niversitätsklinik für Innere Medizin, Abteilung für Nephrologie0 个研究点目标入组 20 人开始时间: 2016年8月11日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Signed informed consent prior to any study specific screening procedures.
•Male or female between 18 and 80 years of age.
•Subjects must have an arteriovenous shunt as vascular access with a blood flow > 450ml/min facilitating a blood flow rate >350ml/min, confirmed by ultrasound.
•Subjects must have a haemoglobin level between 9 and 13g/dl
•At inclusion, all subjects must have been treated for at least 1 month, three times a week with at least 240-min bicarbonate HD using a synthetic biocompatible dialysis membrane
•Subjects must be oligoanuric at the time of randomization (<400ml/day), as reported by the subjects
•Otherwise in stable health as determined by the investigator and based on medical history and routine laboratory test during the screening period.

•History of active, clinically significant, respiratory, gastrointestinal, hepatic, neurologic psychiatric, musculoskeletal, genitourinary, derma-tological, or other disorders that, in the investigator´s opinion, could affect the conduct of the study.
•Subjects who have had any major cardiovascular event within 180 days prior to randomization, including but not limited to: myocardial in-farction, unstable angina, cerebrovascular accident, pulmonary embo-lism, or New York Heart Association Class III or IV heart failure.
•Presence of cancer
•Severe hypertension (SBP >180mmHg prior to start of the dialysis session)
•Severe malnutrition (Albumin <20g/L)
•Uncontrolled secondary hyperparathyroidism (PTH>1000pg/ml)
•Positive serologic test for hepatitis B or hepatitis C or a positive result of test for HIV antibodies within the last 12 months prior to screening.

发起方

niversitätsklinik für Innere Medizin, Abteilung für Nephrologie