Microcirculation During Haemodialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
E.C. Boerma, Medical Centre Leeuwarden
ClinicalTrials.gov Identifier:
NCT01396980
First received: May 31, 2011
Last updated: February 20, 2012
Last verified: February 2012
  Purpose
  • 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
Complication of Hemodialysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sublingual Microcirculatory Flow Measurements During Haemodialysis in Relation to Blood Volume Change

Resource links provided by NLM:


Further study details as provided by Medical Centre Leeuwarden:

Primary Outcome Measures:
  • Difference between sublingual microvascular flow index between 2 types of ultrafiltration [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: September 2011
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
dialysis patients
dialysis patients, stabil, dialysis dependancy for more than 3 months, with adequate access

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • dialysis patient
  • age > 18
  • informed consent

Exclusion Criteria:

  • no adequate access
  • instable hemodynamics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396980

Locations
Netherlands
Medical Centre Leeuwarden
Leeuwarden, Netherlands, 8934 AD
Sponsors and Collaborators
Medical Centre Leeuwarden
Investigators
Principal Investigator: Christiaan Boerma, MD Medical Centre Leeuwarden
  More Information

No publications provided

Responsible Party: E.C. Boerma, Dr, Medical Centre Leeuwarden
ClinicalTrials.gov Identifier: NCT01396980     History of Changes
Other Study ID Numbers: TPO 776
Study First Received: May 31, 2011
Last Updated: February 20, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Medical Centre Leeuwarden:
hemodialysis
intensive care
microcirculation

ClinicalTrials.gov processed this record on April 17, 2014