Microcirculation During Haemodialysis

Status Completed

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

Complication of Hemodialysis

Clinical Trial Details

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

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.