Initial Feasibility Pilot Study of Interdialytic Peritoneal Ultrafiltration to Manage Volume Status in Hemodialysis Patients

115423

Sodium accumulates in the tissues of patients with kidney disease and impairs survival. Three-times weekly, standard hemodialysis alone cannot remove excess sodium efficiently. A sample of 10 chronic hemodialysis patients will undergo a 5-week, pilot, interventional study to test the efficacy of additional sodium removal in-between hemodialysis sessions, twice per week, for three weeks. Tissue sodium removal will be achieved with peritoneal dialysis after the surgical insertion of a peritoneal dialysis catheter. Tissue sodium removal will be assessed at the beginning and at the end of the study with sodium magnetic resonance imaging of a peripheral limb (leg). Patients will also undergo monitoring for symptoms and blood pressure throughout the study to assess the safety of this procedure.

2021-01-01

2024-06-30

2024-12-31

Recruiting

Early phase I

10

Inclusion Criteria * At least one of the following: * Average per-session interdialytic weight gain ≥ 4.0 % of their dry weight in the last month; * Inability to consistently achieve dry weight with the current treatment schedule; * Need for additional HD treatments to achieve prescribed dry weight. * Weekly HD sessions - up to three times/week * Age ≥18 years * Willing and able to give informed consent Exclusion Criteria * Contraindications to peritoneal dialysis * Contraindications to MRI * Uncontrolled diabetes mellitus * Active infections * Non-compliance to hemodialysis prescription * Pre-study serum sodium \< 130 mmol/L

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}

2024-02-09