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Microcirculation During Haemodialysis

Sponsor
Medical Centre Leeuwarden (Other)
Overall Status
Completed
CT.gov ID
NCT01396980
Collaborator
(none)
8
Enrollment
1
Location
5
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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)

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    8 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Sublingual Microcirculatory Flow Measurements During Haemodialysis in Relation to Blood Volume Change
    Study Start Date :
    Sep 1, 2011
    Actual Primary Completion Date :
    Jan 1, 2012
    Actual Study Completion Date :
    Feb 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    dialysis patients

    dialysis patients, stabil, dialysis dependancy for more than 3 months, with adequate access

    Outcome Measures

    Primary Outcome Measures

    1. Difference between sublingual microvascular flow index between 2 types of ultrafiltration [3 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • dialysis patient

    • age > 18

    • informed consent

    Exclusion Criteria:

    • no adequate access

    • instable hemodynamics

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Centre Leeuwarden Leeuwarden Netherlands 8934 AD

    Sponsors and Collaborators

    • Medical Centre Leeuwarden

    Investigators

    • Principal Investigator: Christiaan Boerma, MD, Medical Centre Leeuwarden

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    E.C. Boerma, Dr, Medical Centre Leeuwarden
    ClinicalTrials.gov Identifier:
    NCT01396980
    Other Study ID Numbers:
    • TPO 776
    First Posted:
    Jul 19, 2011
    Last Update Posted:
    Feb 22, 2012
    Last Verified:
    Feb 1, 2012
    Keywords provided by E.C. Boerma, Dr, Medical Centre Leeuwarden
    hemodialysis
    intensive care
    microcirculation

    Study Results

    No Results Posted as of Feb 22, 2012