NCT01362088

Brief Summary

In patients where fluid is withdrawn from the bloodstream by Continuous Venovenous Hemofiltration (CVVH), the ultrafiltration rate will be calculated for a zero balance. From there, the ultrafiltration steps are performed, after increasing the ultrafiltration rate, the sublingual microcirculation is assessed by sidestream dark field (SDF). The images are subsequently randomly analyzed, and the sublingual microcirculation is expressed as a number, the microvascular flow index (MFI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

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 11, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 27, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

November 1, 2012

Status Verified

October 1, 2012

Enrollment Period

1.1 years

First QC Date

May 11, 2011

Last Update Submit

October 31, 2012

Conditions

Continuous Venovenous Hemofiltration

Keywords

microcirculationintensive careultrafiltrationCVVH

Outcome Measures

Primary Outcomes (1)

  • Difference in MFI between zero balance and maximal ultrafiltrationrate (300 ml/hr)

    4 hours

Study Arms (1)

CVVH patients

Eligibility Criteria

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

Intensive Care patients treated with CVVH

You may qualify if:

  • age \> 18 jaar
  • informed consent

You may not qualify if:

  • age \< 18 jaar
  • oral surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Centre Leeuwarden

Leeuwarden, 8934 AD, Netherlands

Location

Related Publications (1)

  • Bemelmans RH, Boerma EC, Barendregt J, Ince C, Rommes JH, Spronk PE. Changes in the volume status of haemodialysis patients are reflected in sublingual microvascular perfusion. Nephrol Dial Transplant. 2009 Nov;24(11):3487-92. doi: 10.1093/ndt/gfp267. Epub 2009 Jun 10.

    PMID: 19515801BACKGROUND

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 11, 2011

First Posted

May 27, 2011

Study Start

September 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

November 1, 2012

Record last verified: 2012-10

Locations

NL(1)