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Clinical Trial Summary

- SDF is validated by measuring changes in microcirculation in sepsis patients with MOF (Boerma studies).

- SDF is validated by measuring changes in microcirculation in stable chronic hemodialysis patients (NDT 2009 Bemelmans).

- Ultrafiltration in stable chronic hemodialysis leads to a decrease in sublingual microcirculatory flow (NDT 2009 Bemelmans).

- Trendelenburg position improves the sublingual microcirculatory flow at the end of hemodialysis treatment (NDT 2009 Bemelmans).

- Hemodialysis with ultrafiltration leads to a significant reduction of myocardial perfusion and cardiac output (NDT 2009 Dasselaar)

- Cardiac output measurement during dialysis is not practical.

- BVM is a validated method for hypotension due to ultrafiltration to prevent the amount of ultrafiltration online change based on the measured haemoconcentration (ref Dasselaar et al NDT 2005).

- BCM is a validated measurement to the dry weight in hemodialysis patients measured by a bioimpedance technique (NDT Passauer et al 2009).


Clinical Trial Description

The search for an optimal method of ultrafiltration with minimal hypoperfusion of vital organs.

- Stabile hemodialysis patients with dialysis dependancy for more than 3 months, with adequate access

- Study duration 3 weeks

- Number of hemodialysis treatment for purposes of study: 3

- Timing hemodialysis treatments for Study session Monday or Tuesday after the weekend (randomized design in the sessions)

- session a: 5 hours total duration: 4 hours HD without UF followed by 1 hour GUF

- Session b: 4 hours total duration: 4 hours HD with UF

- session c: 4 hours total duration: 4 hours HD with UF and BVM

- UF is determined by actual target weight.

- Measurements during sessions:

- In each session in advance: blood pressure, pulse, weight, BCM, laboratory tests (Hb, Hct, Na, K, urea, creatinine, calcium, albumin, phosphate, nt-proBNP, troponin T, CRP)

- During each session at t = 0, t = 1 hour, t =2 hours and t = 4 hours: SDF, blood pressure, pulse, UF at that time, UF rate at that time

- End each session: blood pressure, pulse, weight, BCM, laboratory tests (Hb, Hct, Na, K, urea, creatinine, calcium, albumin, phosphate, nt-proBNP, troponin T, CRP) ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01396980
Study type Observational
Source Medical Centre Leeuwarden
Contact
Status Completed
Phase N/A
Start date September 2011
Completion date February 2012

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