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

History of Changes

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In patients where fluid is withdrawn from the bloodstream by Continuous Venovenous Hemofiltration (CVVH), the ultrafiltration rate will be calculated for a zero balance.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 ]
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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

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:

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. Epub 2009 Jun 10.

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 May 16, 2013

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