Clinical trial NCT01396980: Microcirculation During Haemodialysis
Official title: Sublingual Microcirculatory Flow Measurements During Haemodialysis in Relation to Blood Volume Change
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Hemodialysis
Keywords: hemodialysis
intensive care
microcirculation
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stable hemodialysis patients with dialysis dependancy for more than 3 months, with adequate access

Brief 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).

Detailed 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)

Eligibility criteria: Inclusion Criteria:

* dialysis patient
* age \> 18
* informed consent

Exclusion Criteria:

* no adequate access
* instable hemodynamics

Primary outcomes:
measure: Difference between sublingual microvascular flow index between 2 types of ultrafiltration
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medical Centre Leeuwarden
Study officials:
affiliation: Frisius Medisch Centrum
name: Christiaan Boerma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Veenstra G, Pranskunas A, Skarupskiene I, Pilvinis V, Hemmelder MH, Ince C, Boerma EC. Ultrafiltration rate is an important determinant of microcirculatory alterations during chronic renal replacement therapy. BMC Nephrol. 2017 Feb 20;18(1):71. doi: 10.1186/s12882-017-0483-z.