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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014