Clinical trial NCT01179243: Prevalence of Microcirculatory Alterations in Intensive Care Patients
Official title: Observation of the Prevalence of Sublingual Microcirculatory Alterations With SDF Imaging in Intensive Care Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Keywords: microcirculatory alterations
SDF imaging
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2010-08-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: intensive care patients

Brief 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.

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 criteria: Inclusion Criteria:

* \> 18
* informed consent

Exclusion Criteria:

* injury to the maxillofacial area
* recent maxillofacial injury

Primary outcomes:
measure: microcirculatory alterations related to underlying illness, expressed as - amongst others- microvascular flow index (MFI), proportion of perfused vessels (PPV).
timeFrame: 24 hours
Secondary outcomes:
measure: microcirculatory alterations related to: hospital/intensive care length of stay mortality severity of illness
timeFrame: 28 days
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: OLVG
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuis Apeldoorn
city: Leeuwarden
country: Netherlands
facility: Medical Centre Leeuwarden
city: Rotterdam
country: Netherlands
facility: Erasmus MC Rotterdam
Study officials:
affiliation: Medical Centre Leeuwarden, the Netherlands
name: E.C. Boerma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vellinga NAR, Boerma EC, Koopmans M, Donati A, Dubin A, Shapiro NI, Pearse RM, van der Voort PHJ, Dondorp AM, Bafi T, Fries M, Akarsu-Ayazoglu T, Pranskunas A, Hollenberg S, Balestra G, van Iterson M, Sadaka F, Minto G, Aypar U, Hurtado FJ, Martinelli G, Payen D, van Haren F, Holley A, Gomez H, Mehta RL, Rodriguez AH, Ruiz C, Canales HS, Duranteau J, Spronk PE, Jhanji S, Hubble S, Chierego M, Jung C, Martin D, Sorbara C, Bakker J, Ince C; microSOAP study group. Mildly elevated lactate levels are associated with microcirculatory flow abnormalities and increased mortality: a microSOAP post hoc analysis. Crit Care. 2017 Oct 18;21(1):255. doi: 10.1186/s13054-017-1842-7.
citation: Vellinga NA, Boerma EC, Koopmans M, Donati A, Dubin A, Shapiro NI, Pearse RM, Machado FR, Fries M, Akarsu-Ayazoglu T, Pranskunas A, Hollenberg S, Balestra G, van Iterson M, van der Voort PH, Sadaka F, Minto G, Aypar U, Hurtado FJ, Martinelli G, Payen D, van Haren F, Holley A, Pattnaik R, Gomez H, Mehta RL, Rodriguez AH, Ruiz C, Canales HS, Duranteau J, Spronk PE, Jhanji S, Hubble S, Chierego M, Jung C, Martin D, Sorbara C, Tijssen JG, Bakker J, Ince C; microSOAP Study Group. International study on microcirculatory shock occurrence in acutely ill patients. Crit Care Med. 2015 Jan;43(1):48-56. doi: 10.1097/CCM.0000000000000553.