Prevalence of Microcirculatory Alterations in Intensive Care Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
E.C. Boerma, Medical Centre Leeuwarden
ClinicalTrials.gov Identifier:
NCT01179243
First received: August 3, 2010
Last updated: October 31, 2012
Last verified: October 2012
  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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • microcirculatory alterations related to: hospital/intensive care length of stay mortality severity of illness [ Time Frame: 28 days ] [ Designated as safety issue: No ]

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

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

Criteria

Inclusion Criteria:

  • > 18
  • informed consent

Exclusion Criteria:

  • injury to the maxillofacial area
  • recent maxillofacial injury
  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: 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

No publications provided

Responsible Party: E.C. Boerma, MD PhD, Medical Centre Leeuwarden
ClinicalTrials.gov Identifier: NCT01179243     History of Changes
Other Study ID Numbers: TPO 702
Study First Received: August 3, 2010
Last Updated: October 31, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Medical Centre Leeuwarden:
microcirculatory alterations
SDF imaging

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014