Critical IllnessNCT01179243
Prevalence of Microcirculatory Alterations in Intensive Care Patients
An observational study of Critical Illness, run by Frisius Medisch Centrum at 4 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 500 participants
- Where
- 4 sitesNetherlands
- Study dates
- Sep 2011to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: intensive care patients
Who may be able to join
- > 18
- informed consent
Who cannot join
- injury to the maxillofacial area
- recent maxillofacial injury
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
OLVG
Amsterdam
Gelre Ziekenhuis Apeldoorn
Apeldoorn
Medical Centre Leeuwarden
Leeuwarden, 8934 AD
Erasmus MC Rotterdam
Rotterdam
About this study
Official title: Observation of the Prevalence of Sublingual Microcirculatory Alterations With SDF Imaging in Intensive Care Patients
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.
Read the 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.
- Conditions
- Critical Illness
- Keywords
- microcirculatory alterations, SDF imaging
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| intensive care patients | no interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
microcirculatory alterations related to underlying illness, expressed as - amongst others- microvascular flow index (MFI), proportion of perfused vessels (PPV).
Measured: 24 hours
Secondary outcomes (1)
microcirculatory alterations related to: hospital/intensive care length of stay mortality severity of illness
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E.C. Boerma, Frisius Medisch Centrum
- Investigators
- E.C. Boerma, MD, PhD, Principal investigator, Medical Centre Leeuwarden, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179243
- Sponsor's protocol ID
- TPO 702
- Status last verified
- Oct 2012
- First submitted
- 3 Aug 2010
- Last updated
- 1 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29047411Vellinga 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.
PubMed 25126880
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of the Prevalence of Sublingual Microcirculatory Alterations With SDF Imaging in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT01179243
- Acronym / sponsor ID
- TPO 702
- Conditions
- Critical Illness
- Keywords
- microcirculatory alterations, SDF imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 11 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intensive care patients | – | –no interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- intensive care patients
Key inclusion criteria (2 listed)
- > 18
- informed consent
Key exclusion criteria (2 listed)
- injury to the maxillofacial area
- recent maxillofacial injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
microcirculatory alterations related to underlying illness, expressed as - amongst others- microvascular flow index (MFI), proportion of perfused vessels (PPV).
Time frame: 24 hours
1 secondary outcome
microcirculatory alterations related to: hospital/intensive care length of stay mortality severity of illness
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2012.
- Derived from this study: PubMed 29047411Vellinga 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.
- Derived from this study: PubMed 25126880Vellinga 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E.C. Boerma, MD, PhD principal investigator
Medical Centre Leeuwarden, the Netherlands
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Frisius Medisch Centrum at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microcirculatory alterations related to underlying illness, expressed as - amongst others- microvascular flow index (MFI), proportion of perfused vessels (PPV). (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01179243, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2012.