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Prevalence of Microcirculatory Alterations in Intensive Care Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01179243
First Posted: August 11, 2010
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

Recent research has focused on the investigation of sublingual microcirculatory alterations in different patient categories, like cardiac surgery and sepsis. The microcirculation plays a pivotal role in tissue oxygenation and can be non invasively visualized by sidestream dark field (SDF) imaging.

The objective is to carry out a international multi center study to investigate the prevalence of microcirculatory alterations in intensive care patients. Up to the present time, a comprehensive prevalence study like this has not been carried out.


Condition
Critical Illness

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Observation of the Prevalence of Sublingual Microcirculatory Alterations With SDF Imaging in Intensive Care Patients

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

Primary Outcome Measures:
  • microcirculatory alterations related to underlying illness, expressed as - amongst others- microvascular flow index (MFI), proportion of perfused vessels (PPV). [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • microcirculatory alterations related to: hospital/intensive care length of stay mortality severity of illness [ Time Frame: 28 days ]

Enrollment: 500
Study Start Date: September 2011
Study Completion Date: May 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
intensive care patients
no interventions

Detailed Description:
Visualization of the sublingual microcirculation at a fixed time point with SDF- or OPS-imaging in all adult patients of participating intensive care units, regardless of their underlying disease. Concurrently, data on both patient characteristics (e.g. severity of illness, treatment) and ICU characteristics will be obtained.
  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
Criteria

Inclusion Criteria:

  • > 18
  • informed consent

Exclusion Criteria:

  • injury to the maxillofacial area
  • recent maxillofacial injury
  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): NCT01179243


Locations
Netherlands
OLVG
Amsterdam, Netherlands
Gelre Ziekenhuis Apeldoorn
Apeldoorn, Netherlands
Medical Centre Leeuwarden
Leeuwarden, Netherlands, 8934 AD
Erasmus MC Rotterdam
Rotterdam, Netherlands
Sponsors and Collaborators
Medical Centre Leeuwarden
Investigators
Principal Investigator: E.C. Boerma, MD, PhD Medical Centre Leeuwarden, the Netherlands
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: E.C. Boerma, MD PhD, Medical Centre Leeuwarden
ClinicalTrials.gov Identifier: NCT01179243     History of Changes
Other Study ID Numbers: TPO 702
First Submitted: August 3, 2010
First Posted: August 11, 2010
Last Update Posted: November 1, 2012
Last Verified: October 2012

Keywords provided by E.C. Boerma, Medical Centre Leeuwarden:
microcirculatory alterations
SDF imaging

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes