NCT01179243

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2010

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

November 1, 2012

Status Verified

October 1, 2012

Enrollment Period

3 months

First QC Date

August 3, 2010

Last Update Submit

October 31, 2012

Conditions

Keywords

microcirculatory alterationsSDF imaging

Outcome Measures

Primary Outcomes (1)

  • microcirculatory alterations related to underlying illness, expressed as - amongst others- microvascular flow index (MFI), proportion of perfused vessels (PPV).

    24 hours

Secondary Outcomes (1)

  • microcirculatory alterations related to: hospital/intensive care length of stay mortality severity of illness

    28 days

Study Arms (1)

intensive care patients

no interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

intensive care patients

You may qualify if:

  • \> 18
  • informed consent

You may not qualify if:

  • injury to the maxillofacial area
  • recent maxillofacial injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

OLVG

Amsterdam, Netherlands

Location

Gelre Ziekenhuis Apeldoorn

Apeldoorn, Netherlands

Location

Medical Centre Leeuwarden

Leeuwarden, 8934 AD, Netherlands

Location

Erasmus MC Rotterdam

Rotterdam, Netherlands

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • E.C. Boerma, MD, PhD

    Medical Centre Leeuwarden, the Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

August 3, 2010

First Posted

August 11, 2010

Study Start

September 1, 2011

Primary Completion

December 1, 2011

Study Completion

May 1, 2012

Last Updated

November 1, 2012

Record last verified: 2012-10

Locations