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Completed

NCT Number: NCT01396980

Microcirculation During Haemodialysis

* 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Centre Leeuwarden

Leeuwarden, 8934 AD, Netherlands

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • dialysis patient
  • age > 18
  • informed consent

Exclusion criteria

  • no adequate access
  • instable hemodynamics

Treatment and study plan

Primary outcomes

  1. Difference between sublingual microvascular flow index between 2 types of ultrafiltration

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Frisius Medisch Centrum

Other

Registry information

Official study title

Sublingual Microcirculatory Flow Measurements During Haemodialysis in Relation to Blood Volume Change

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 19, 2011
Registry last updated
Feb 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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