Microcirculation in Continuous Venovenous Hemofiltration Patients on the Intensive Care Unit

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
E.C. Boerma, Medical Centre Leeuwarden
ClinicalTrials.gov Identifier:
NCT01362088
First received: May 11, 2011
Last updated: October 31, 2012
Last verified: October 2012
  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In patients where fluid is withdrawn from the bloodstream by Continuous Venovenous Hemofiltration (CVVH), the ultrafiltration rate will be calculated for a zero balance.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 Medical Centre Leeuwarden:

Primary Outcome Measures:
  • Difference in MFI between zero balance and maximal ultrafiltrationrate (300 ml/hr) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    -


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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
Study First Received: May 11, 2011
Last Updated: October 31, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Medical Centre Leeuwarden:
microcirculation
intensive care
ultrafiltration
CVVH

ClinicalTrials.gov processed this record on September 22, 2014