The Effect of On-Line Hemodiafiltration Versus High Flux Hemodialysis on Hemodynamic Parameters in Patients With Intra-Dialytic Hypotension
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Total peripheral resistance (dynes/sec/cm5)
Study Overview
Brief Summary
Rationale and objectives
- Patients on On Line Hemodiafiltration (OL- HDF) are more stable hemodynamically with less Intra Dialytic Hypotension (IDH) episodes compared to conventional hemodialysis (HD). The investigator will follow the hemodynamic parameters during the dialysis sessions (HD and OL-HDF) by using the new non invasive technology, the NICAS device.
- By switching each patient with IDH from HD to OL- HDF, the investigators will evaluate the hemodynamic parameters and compare the two renal replacement treatment modalities, and prove the superiority of OL-HDF over HD regarding the hemodynamic measures.
Detailed Description
Intradialytic hypotension (IDH) or a significant fall in blood pressure (BP) is the most common complication that occurs during hemodialysis (HD) treatment, occurring in up to 20-33% of sessions.
Different mechanisms are involved in the pathogenesis of IDH including acute central hypovolemia, may be precipitated by rapid or excessive ultrafiltration that lead to intravascular volume depletion beyond the level of hemodynamic compensatory response. Other proposed mechanisms of intra vascular depletion are volume shift into the extra-vascular space due to rapid reduction in plasma osmolality, slow and incompatible vascular refilling rate and incorrectly low prescribed dry weight.
Autonomic dysfunction occurs in considerable amount of dialysis patients up to about 50% . This dysfunction reduces the ability to produce an adequate sympathetic response in the setting of acute volume diminution.
Due to the complexity of the dialysis treatment and absence of non- invasive technology, few studies followed the hemodynamic changes which occur during a dialysis session especially during IDH episodes.
OL- HDF is a relatively new method of therapy that allows a larger volume of blood filtration during a single dialysis therapy compared with standard hemodialysis.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients affected by IDH during one or more dialytic sessions every week
Exclusion Criteria
- •Patients with recent change in chronic medications, chronic liver disease, recent acute coronary event, cardiac arrhythmias and acute infection.
Arms & Interventions
High Flux Hemodialysis
Intervention: NICaS (Device)
OL-HDF
Intervention: NICaS (Device)
Outcomes
Primary Outcomes
Total peripheral resistance (dynes/sec/cm5)
Time Frame: 5 weeks
The superiority of OL-HDF over regular hemodialysis in decreasing the frequency of intradialytic hypertension episodes.
Time Frame: 5 weeks
Mean arterial pressure (mm/Hg)
Time Frame: 5 weeks
Cardiac index (l/min/m2)
Time Frame: 5 weeks
Secondary Outcomes
No secondary outcomes reported
