Prevalence of Microcirculatory Alterations in Intensive Care Patients

Critical Illness Clinical Trial

Official title:

Observation of the Prevalence of Sublingual Microcirculatory Alterations With SDF Imaging in Intensive Care Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179243
• Other study ID #: TPO 702
• Status: Completed
• Phase: N/A
• First received: August 3, 2010
• Last updated: October 31, 2012
• Start date: September 2011
• Est. completion date: May 2012

Study information

• Verified date: October 2012
• Source: Medical Centre Leeuwarden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• > 18

• informed consent

Exclusion Criteria:

• injury to the maxillofacial area

• recent maxillofacial injury

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Critical Illness

Locations

Country	Name	City	State
Netherlands	OLVG	Amsterdam
Netherlands	Gelre Ziekenhuis Apeldoorn	Apeldoorn
Netherlands	Medical Centre Leeuwarden	Leeuwarden
Netherlands	Erasmus MC Rotterdam	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Medical Centre Leeuwarden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	microcirculatory alterations related to underlying illness, expressed as - amongst others- microvascular flow index (MFI), proportion of perfused vessels (PPV).		24 hours	No
Secondary	microcirculatory alterations related to: hospital/intensive care length of stay mortality severity of illness		28 days	No