NCT01396980

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 19, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

Enrollment Period

4 months

First QC Date

May 31, 2011

Last Update Submit

February 20, 2012

Conditions

Keywords

hemodialysisintensive caremicrocirculation

Outcome Measures

Primary Outcomes (1)

  • Difference between sublingual microvascular flow index between 2 types of ultrafiltration

    3 weeks

Study Arms (1)

dialysis patients

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • dialysis patient
  • age \> 18
  • informed consent

You may not qualify if:

  • no adequate access
  • instable hemodynamics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Centre Leeuwarden

Leeuwarden, 8934 AD, Netherlands

Location

Related Publications (1)

  • 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.

Study Officials

  • Christiaan Boerma, MD

    Frisius Medisch Centrum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 31, 2011

First Posted

July 19, 2011

Study Start

September 1, 2011

Primary Completion

January 1, 2012

Study Completion

February 1, 2012

Last Updated

February 22, 2012

Record last verified: 2012-02

Locations