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Microcirculation in Continuous Venovenous Hemofiltration Patients on the Intensive Care Unit

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01362088
First Posted: May 27, 2011
Last Update Posted: November 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
E.C. Boerma, Medical Centre Leeuwarden
  Purpose
In patients where fluid is withdrawn from the bloodstream by Continuous Venovenous Hemofiltration (CVVH), the ultrafiltration rate will be calculated for a zero balance.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).

Condition
Continuous Venovenous Hemofiltration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Sublingual Microcirculation by Means of SDF Imaging by Stepwise Ultrafiltration in CVVH Patients on the ICU

Further study details as provided by E.C. Boerma, Medical Centre Leeuwarden:

Primary Outcome Measures:
  • Difference in MFI between zero balance and maximal ultrafiltrationrate (300 ml/hr) [ Time Frame: 4 hours ]

Enrollment: 14
Study Start Date: September 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
CVVH patients

Detailed Description:

Before deciding to threat a patient actively with CVVH, a target balance will be agreed for the next 12 hours. Then the ultrafiltration rate for the zero balance is calculated. From there, the ultrafiltration rate progressively increased to 50 ml per hour, up to a maximum ultrafiltration rate of 300 ml per hour.

After each increase of the ultrafiltration rate, the sublingual microcirculation is assessed by SDF.

After obtaining the desired ultrafiltration rate, the microcirculation will again be assessed before and after the patient is temporarily placed in Trendelenburg position. This could possibly show that underfill has the greatest influence on the microcirculation, and not other factors like a rising hematocrit.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Intensive Care patients treated with CVVH
Criteria

Inclusion Criteria:

  • age > 18 jaar
  • informed consent

Exclusion Criteria:

  • age < 18 jaar
  • oral surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362088


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

Publications:
Responsible Party: E.C. Boerma, Dr, Medical Centre Leeuwarden
ClinicalTrials.gov Identifier: NCT01362088     History of Changes
Other Study ID Numbers: TPO 767
First Submitted: May 11, 2011
First Posted: May 27, 2011
Last Update Posted: November 1, 2012
Last Verified: October 2012

Keywords provided by E.C. Boerma, Medical Centre Leeuwarden:
microcirculation
intensive care
ultrafiltration
CVVH