Microcirculation During Haemodialysis

February 20, 2012 updated by: E.C. Boerma, Medical Centre Leeuwarden

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

  • 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).

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Leeuwarden, Netherlands, 8934 AD
        • Medical Centre Leeuwarden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • dialysis patient
  • age > 18
  • informed consent

Exclusion Criteria:

  • no adequate access
  • instable hemodynamics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference between sublingual microvascular flow index between 2 types of ultrafiltration
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Centre Leeuwarden

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

May 31, 2011

First Submitted That Met QC Criteria

July 18, 2011

First Posted (Estimate)

July 19, 2011

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 20, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TPO 776

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Complication of Hemodialysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe