Critical IllnessMICRODAIMONNCT02649088
Sublingual Microcirculation Monitoring in ICU
An observational study of Critical Illness, run by Università Politecnica delle Marche at 1 site in Italy.
Trial summary
Prospective observational study designed to implement a daily monitoring of microcirculation and tissue oxygenation in all critically ill patients admitted to the ICU in the period of nine months, in order to assess the prevalence of microvascular perfusion abnormalities and their relation to: outcomes, underlying… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Illness
- What is being tested?
- Microscan and NIRS from Hutchinson
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2013to Apr 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients admitted in intensive care unit
Who may be able to join
- adult patients admitted in ICU
Who cannot join
- age <18
- expected ICU length of stay <24 hrs
- any conditions that preclude sublingual microcirculatory evaluation (e.g. facial trauma)
- readmitted patients previously enrolled in the present study
Trial locations and contacts
1 site in 1 country.
Italy1 site
University ICU, AOU Ospedali Riuniti Ancona
Torrette Di Ancona, Ancona, 60126
About this study
Prospective observational study designed to implement a daily monitoring of microcirculation and tissue oxygenation in all critically ill patients admitted to the ICU in the period of nine months, in order to assess the prevalence of microvascular perfusion abnormalities and their relation to: outcomes, underlying disease, hospital stay, clinical-laboratory and hemodynamic parameters commonly measured, indices of clinical severity and predictors of mortality , therapeutic interventions that are part of routine clinical practice (fluids, sedation, vasopressors, inotropes, anticoagulants, renal replacement therapy, blood transfusion). The study also includes the evaluation of sublingual microcirculation and tissue oxygenation in 30 healthy volunteers to compare normal and pathological conditions. Within the first 12 hours after admission to ICU and every 24 hours for the duration of hospitalization, the following evaluations will be made: -study of sublingual microcirculation using sidestream dark field (SDF) imaging, muscle tissue oxygenation using near infrared spectroscopy (NIRS). The data will be analyzed to test correlation between the outcome of patients admitted in ICU and microcirculatory parameters.
Read the detailed description
The aim of this study is to daily assess microcirculation and tissue oxygenation in all critically ill patients admitted to the ICU during a period of nine months, in order to assess the prevalence of microvascular perfusion abnormalities and their relation to: outcomes, underlying disease, duration of hospitalization, clinical-laboratory and hemodynamic parameters commonly measured, indices of clinical severity and predictors of mortality (SAPS II , APACHE II , SOFA score , PIRO score ), therapeutic interventions are part of common clinical practice (fluids, sedation, vasopressors, inotropes, anticoagulants, renal replacement therapy, blood transfusion). In order to implement a comparison between normal and pathological conditions, sublingual microcirculation and tissue oxygenation will be assessed "una tantum" in 35 healthy volunteers.
STATISTICAL ANALYSIS: Descriptive statistics will be used to describe the population of patients recruited. The prevalence of Microcirculatory abnormalities will be assessed in the general population and in distinct patient subgroups based on the underlying disease. Receiver operator curve (ROC) Curves will be used to determine cut-off values for Microcirculatory variabile s related to morbidity and mortality. It will be assessed the correlation between variables and Microcirculatory: hemodynamic parameters and laboratory, length of stay in ICU/hospital, APACHE II, SAPS II, mortality, SOFA, PIRO score (the latter for septic patients). Multivariate analysis will be used to assess the association between Microcirculatory alterations and other variables. Microcirculatory differences among various subgroups (differentiated by outcome, underlying disease, severity indices, therapies; if sepsis: site of infection) will be assessed using t-test (for normally distributed variables) or with non-parametric tests for not normally distributed variables.
MATERIAL AND METHODS: ICU is divided into three subunits: Respiratory ICU, Medical ICU and Trauma ICU with 4 beds each. All patients admitted in each subunit have been daily monitored from the admission until the discharge for a period of 3 months. The subunits will be included in the study not at the same time but sequentially so that the total period for monitoring will be of 9 months. In order to implement a comparison between normal and pathological conditions, sublingual microcirculation and tissue oxygenation are evaluated in 35 healthy volunteers, which will be adequately informed of the aims and methods of the study and will give their written consent. The comparison between healthy volunteers and patients is necessary because the normal values for Microcirculatory parameters have not yet been established. It should be noted that all healthy volunteers will be recruited within the current staff of ICU and measurements will be performed only once. Within the first 12 hours after admission and every 24 hours for the duration of hospitalization, sublingual microcirculation is evaluated by using the technique of sidestream dark field (SDF) imaging currently used in our Department (Microscan, Microvision Medical, Amsterdam, The Netherlands). Contextually sublingual microcirculation study, tissue oxygenation will be evaluated using near infrared spectroscopy (NIRS), already in widespread use in our clinical practice (InSpectra ™ Model 650; Hutchinson Technology Inc., Hutchinson, MN, USA, nr. inventory status: 15852). For each patient the following data will be collected: age, sex, diagnosis, APACHE II, SAPS II, past medical history (arterial hypertension, diabetes mellitus, chronic renal failure, cardiovascular, cerebrovascular, liver cirrhosis, immune deficiencies, therapy with beta-blockers, Nitro), results of microbiological tests, SOFA score, PIRO score (septic patients), length of stay in hospital and in intensive care, outcome. Every day, parameters routinely assessed in clinical practice will be collected: body temperature, heart rate, mean arterial pressure, hemodynamic parameters (where femoral catheter already exists Cardiac index (CI), Intrathoracic blood volume ( ITBVI), EVLWI), blood gas analysis parameters (pH, PaO2, PaCO2, BE, PaO2/FiO2, lactates); fluid balance, diuresis; complete blood count (hemoglobin, hematocrit, WBC, RBC, PLT), creatinine, glucose (from arterial blood drawn for abgs-analysis), total bilirubin, PCR, Procalcitonin (if any), INR, PT, PTT, Fibrinogen; therapies: analgo-sedation, inotropes, vasopressors, blood transfusion, fluids. EVALUATION OF MICROCIRCULATION After removing any secretions with gauze, the probe will be gently applied to the sublingual mucosa without exerting excessive pressure. At each timepoint, videos from 3-5 different sites of a minimum duration of 10 seconds each will record. After assigning a random number, the images will be analyzed with a dedicated software and, in accordance with the criteria established in a roundtable of experts in 2007 [17], laid down the following variables: De Backer score, Total Vessel Density (TVD) and hearts Perfused Vessel Density (PVD), which indexes the density of perfused vessels; Microvascular Flow Index (MFI) and Proportion of Perfused Vessels (PPV), perfusion quality indices; Flow Heterogeneity Index (HI), index of homogeneity of flow distribution. The images will also be analyzed using the ICU GlycoCheck (Maastricht University Medical Center, Maastricht, The Netherlands, www.glycocheck.com) to get the value of the Perfused Boundary Region (PBR, micron), which represents the thickness of the permeable of glycocalyx that allows the penetration of erythrocytes, damage index of glycocalyx. TISSUE OXYGENATION ASSESSMENT Tissue oxygenation is assessed at rest and during a test of forearm vascular occlusion. NIRS probe will be placed at the level of the thenar eminence and the cuff of a sphygmomanometer around the forearm; After 3 minutes the signal stabilisation, the cuff is inflated to a pressure 40 mmHg higher than the patient's systolic to block the flow of blood. You will wait so that the descent of StO2 until 40% prior to deflate the cuff. The rate of descent of StO2 ischemic phase (StO2 downslope) is an indication of extraction and consumption of O2; the ascent rate during reperfusion (StO2 upslope), along with the area under the curve during the next stage of reactive hyperemia (AUC StO2), is an indication of the reactivity of the micro-circulation. It should be noted that vascular occlusion testing is absolutely harmless, because the phase of ischemia is too short (usually 2-3 minutes at most) in order to cause any ischemic damage to the tissues of the limb. The Tissue Hemoglobin Index (THI), reflecting the contents of Hb in volume of muscle tissues assessed by the probe, depends not only by blood levels of Hb, but also the density of capillaries perfused.
Finally glycocalyx assessment will be done and it will compared among volunteers, septic critically ill patients and non-septic critically ill patients.
- Conditions
- Critical Illness
- Being tested
- Microscan, NIRS from Hutchinson
- Keywords
- microcirculation, tissue oxygenation, outcome
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroscanDevice
It allows to look at sublingual microcirculation
NIRS from HutchinsonDevice
It allows to monitor tissue oxygen saturation
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between changes in perfused vessel density and 90 days mortality from ICU admission
The perfused vessel density (PVD) is defined as the quantity (mm/mmq) of microcirculatory vessels which have a good flow and it is calculated using a dedicated software described elsewhere.
Measured: 90 days
Correlation between changes in StO2 upload and 90 days mortality from ICU admission
During vascular occlusion test, the changes of StO2 and StO2 values can divided into 3 epoch; Desaturation (StO2 download), Reoxygenation (StO2 upload), and Reactive hyperemia. After data collection, the rate of desaturation and reoxygenation are calculated.
Measured: 90 days
Secondary outcomes (6)
Correlation between Perfused vessel density and central venous saturation
The perfused vessel density (PVD) is defined as the quantity (mm/mmq) of microcirculatory vessels which have a good flow and it is calculated using a dedicated software described elsewhere. Central Venous Saturation is measured from a blood sample from a central venous catheter.
Measured: Study frame: nine months
Correlation between Perfused vessel density and blood lactate
Measured: Study frame: nine months
Correlation between Perfused vessel density and ICU length of stay
Measured: Study frame: nine months
Correlation between Perfused vessel density and hospital length of stay
Measured: Study frame: nine months
Correlation between Perfused vessel density and SOFA score
Measured: Study frame: nine months
Glycocalyx assessment among volunteers, septic and non septic critically ill patients
Glycocalyx is indirectly measured using a dedicated software as described in a previous paper
Measured: Study frame: nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionApr 2014
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Politecnica delle Marche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abele Donati, MD, Università Politecnica delle Marche
- Investigators
- Abele Donati, MD, Principal investigator, Università Politecnica delle Marche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649088
- Sponsor's protocol ID
- 212639
- Acronym
- MICRODAIMON
- Status last verified
- Jan 2016
- First submitted
- 23 Dec 2015
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Scorcella C, Damiani E, Domizi R, Pierantozzi S, Tondi S, Carsetti A, Ciucani S, Monaldi V, Rogani M, Marini B, Adrario E, Romano R, Ince C, Boerma EC, Donati A. MicroDAIMON study: Microcirculatory DAIly MONitoring in critically ill patients: a prospective observational study. Ann Intensive Care. 2018 May 15;8(1):64. doi: 10.1186/s13613-018-0411-9.
PubMed 29766322Donati A, Damiani E, Domizi R, Scorcella C, Carsetti A, Tondi S, Monaldi V, Adrario E, Romano R, Pelaia P, Singer M. Near-infrared spectroscopy for assessing tissue oxygenation and microvascular reactivity in critically ill patients: a prospective observational study. Crit Care. 2016 Oct 1;20(1):311. doi: 10.1186/s13054-016-1500-5.
PubMed 27716370
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Microcirculation Monitoring in ICU
- ClinicalTrials.gov ID
- NCT02649088
- Acronym / sponsor ID
- MICRODAIMON / 212639
- Conditions
- Critical Illness
- Keywords
- microcirculation, tissue oxygenation, outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Università Politecnica delle MarcheUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 7 Jan 2016 (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.
Prospective observational study designed to implement a daily monitoring of microcirculation and tissue oxygenation in all critically ill patients admitted to the ICU in the period of nine months, in order to assess the prevalence of microvascular perfusion abnormalities and their relation to: outcomes, underlying disease, hospital stay, clinical-laboratory and hemodynamic parameters commonly measured, indices of clinical severity and predictors of mortality , therapeutic interventions that are part of routine clinical practice (fluids, sedation, vasopressors, inotropes, anticoagulants, renal replacement therapy, blood transfusion). The study also includes the evaluation of sublingual microcirculation and tissue oxygenation in 30 healthy volunteers to compare normal and pathological conditions. Within the first 12 hours after admission to ICU and every 24 hours for the duration of hospitalization, the following evaluations will be made: -study of sublingual microcirculation using sidestream dark field (SDF) imaging, muscle tissue oxygenation using near infrared spectroscopy (NIRS). The data will be analyzed to test correlation between the outcome of patients admitted in ICU and microcirculatory parameters.
Detailed description
The aim of this study is to daily assess microcirculation and tissue oxygenation in all critically ill patients admitted to the ICU during a period of nine months, in order to assess the prevalence of microvascular perfusion abnormalities and their relation to: outcomes, underlying disease, duration of hospitalization, clinical-laboratory and hemodynamic parameters commonly measured, indices of clinical severity and predictors of mortality (SAPS II , APACHE II , SOFA score , PIRO score ), therapeutic interventions are part of common clinical practice (fluids, sedation, vasopressors, inotropes, anticoagulants, renal replacement therapy, blood transfusion). In order to implement a comparison between normal and pathological conditions, sublingual microcirculation and tissue oxygenation will be assessed "una tantum" in 35 healthy volunteers.
STATISTICAL ANALYSIS: Descriptive statistics will be used to describe the population of patients recruited. The prevalence of Microcirculatory abnormalities will be assessed in the general population and in distinct patient subgroups based on the underlying disease. Receiver operator curve (ROC) Curves will be used to determine cut-off values for Microcirculatory variabile s related to morbidity and mortality. It will be assessed the correlation between variables and Microcirculatory: hemodynamic parameters and laboratory, length of stay in ICU/hospital, APACHE II, SAPS II, mortality, SOFA, PIRO score (the latter for septic patients). Multivariate analysis will be used to assess the association between Microcirculatory alterations and other variables. Microcirculatory differences among various subgroups (differentiated by outcome, underlying disease, severity indices, therapies; if sepsis: site of infection) will be assessed using t-test (for normally distributed variables) or with non-parametric tests for not normally distributed variables.
MATERIAL AND METHODS: ICU is divided into three subunits: Respiratory ICU, Medical ICU and Trauma ICU with 4 beds each. All patients admitted in each subunit have been daily monitored from the admission until the discharge for a period of 3 months. The subunits will be included in the study not at the same time but sequentially so that the total period for monitoring will be of 9 months. In order to implement a comparison between normal and pathological conditions, sublingual microcirculation and tissue oxygenation are evaluated in 35 healthy volunteers, which will be adequately informed of the aims and methods of the study and will give their written consent. The comparison between healthy volunteers and patients is necessary because the normal values for Microcirculatory parameters have not yet been established. It should be noted that all healthy volunteers will be recruited within the current staff of ICU and measurements will be performed only once. Within the first 12 hours after admission and every 24 hours for the duration of hospitalization, sublingual microcirculation is evaluated by using the technique of sidestream dark field (SDF) imaging currently used in our Department (Microscan, Microvision Medical, Amsterdam, The Netherlands). Contextually sublingual microcirculation study, tissue oxygenation will be evaluated using near infrared spectroscopy (NIRS), already in widespread use in our clinical practice (InSpectra ™ Model 650; Hutchinson Technology Inc., Hutchinson, MN, USA, nr. inventory status: 15852). For each patient the following data will be collected: age, sex, diagnosis, APACHE II, SAPS II, past medical history (arterial hypertension, diabetes mellitus, chronic renal failure, cardiovascular, cerebrovascular, liver cirrhosis, immune deficiencies, therapy with beta-blockers, Nitro), results of microbiological tests, SOFA score, PIRO score (septic patients), length of stay in hospital and in intensive care, outcome. Every day, parameters routinely assessed in clinical practice will be collected: body temperature, heart rate, mean arterial pressure, hemodynamic parameters (where femoral catheter already exists Cardiac index (CI), Intrathoracic blood volume ( ITBVI), EVLWI), blood gas analysis parameters (pH, PaO2, PaCO2, BE, PaO2/FiO2, lactates); fluid balance, diuresis; complete blood count (hemoglobin, hematocrit, WBC, RBC, PLT), creatinine, glucose (from arterial blood drawn for abgs-analysis), total bilirubin, PCR, Procalcitonin (if any), INR, PT, PTT, Fibrinogen; therapies: analgo-sedation, inotropes, vasopressors, blood transfusion, fluids. EVALUATION OF MICROCIRCULATION After removing any secretions with gauze, the probe will be gently applied to the sublingual mucosa without exerting excessive pressure. At each timepoint, videos from 3-5 different sites of a minimum duration of 10 seconds each will record. After assigning a random number, the images will be analyzed with a dedicated software and, in accordance with the criteria established in a roundtable of experts in 2007 [17], laid down the following variables: De Backer score, Total Vessel Density (TVD) and hearts Perfused Vessel Density (PVD), which indexes the density of perfused vessels; Microvascular Flow Index (MFI) and Proportion of Perfused Vessels (PPV), perfusion quality indices; Flow Heterogeneity Index (HI), index of homogeneity of flow distribution. The images will also be analyzed using the ICU GlycoCheck (Maastricht University Medical Center, Maastricht, The Netherlands, www.glycocheck.com) to get the value of the Perfused Boundary Region (PBR, micron), which represents the thickness of the permeable of glycocalyx that allows the penetration of erythrocytes, damage index of glycocalyx. TISSUE OXYGENATION ASSESSMENT Tissue oxygenation is assessed at rest and during a test of forearm vascular occlusion. NIRS probe will be placed at the level of the thenar eminence and the cuff of a sphygmomanometer around the forearm; After 3 minutes the signal stabilisation, the cuff is inflated to a pressure 40 mmHg higher than the patient's systolic to block the flow of blood. You will wait so that the descent of StO2 until 40% prior to deflate the cuff. The rate of descent of StO2 ischemic phase (StO2 downslope) is an indication of extraction and consumption of O2; the ascent rate during reperfusion (StO2 upslope), along with the area under the curve during the next stage of reactive hyperemia (AUC StO2), is an indication of the reactivity of the micro-circulation. It should be noted that vascular occlusion testing is absolutely harmless, because the phase of ischemia is too short (usually 2-3 minutes at most) in order to cause any ischemic damage to the tissues of the limb. The Tissue Hemoglobin Index (THI), reflecting the contents of Hb in volume of muscle tissues assessed by the probe, depends not only by blood levels of Hb, but also the density of capillaries perfused.
Finally glycocalyx assessment will be done and it will compared among volunteers, septic critically ill patients and non-septic critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted in intensive care unit
Key inclusion criteria (1 listed)
- adult patients admitted in ICU
Key exclusion criteria (4 listed)
- age <18
- expected ICU length of stay <24 hrs
- any conditions that preclude sublingual microcirculatory evaluation (e.g. facial trauma)
- readmitted patients previously enrolled in the present study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroscanIt allows to look at sublingual microcirculation | Device | – |
| NIRS from HutchinsonIt allows to monitor tissue oxygen saturation | Device | – |
Primary outcome
Correlation between changes in perfused vessel density and 90 days mortality from ICU admission
Time frame: 90 days
The perfused vessel density (PVD) is defined as the quantity (mm/mmq) of microcirculatory vessels which have a good flow and it is calculated using a dedicated software described elsewhere.
Correlation between changes in StO2 upload and 90 days mortality from ICU admission
Time frame: 90 days
During vascular occlusion test, the changes of StO2 and StO2 values can divided into 3 epoch; Desaturation (StO2 download), Reoxygenation (StO2 upload), and Reactive hyperemia. After data collection, the rate of desaturation and reoxygenation are calculated.
6 secondary outcomes
Correlation between Perfused vessel density and central venous saturation
Time frame: Study frame: nine months
Correlation between Perfused vessel density and blood lactate
Time frame: Study frame: nine months
Correlation between Perfused vessel density and ICU length of stay
Time frame: Study frame: nine months
Correlation between Perfused vessel density and hospital length of stay
Time frame: Study frame: nine months
Correlation between Perfused vessel density and SOFA score
Time frame: Study frame: nine months
Glycocalyx assessment among volunteers, septic and non septic critically ill patients
Time frame: Study frame: nine months
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 7 Jan 2016.
- Derived from this study: PubMed 29766322Scorcella C, Damiani E, Domizi R, Pierantozzi S, Tondi S, Carsetti A, Ciucani S, Monaldi V, Rogani M, Marini B, Adrario E, Romano R, Ince C, Boerma EC, Donati A. MicroDAIMON study: Microcirculatory DAIly MONitoring in critically ill patients: a prospective observational study. Ann Intensive Care. 2018 May 15;8(1):64. doi: 10.1186/s13613-018-0411-9.
- Derived from this study: PubMed 27716370Donati A, Damiani E, Domizi R, Scorcella C, Carsetti A, Tondi S, Monaldi V, Adrario E, Romano R, Pelaia P, Singer M. Near-infrared spectroscopy for assessing tissue oxygenation and microvascular reactivity in critically ill patients: a prospective observational study. Crit Care. 2016 Oct 1;20(1):311. doi: 10.1186/s13054-016-1500-5.
- Individual participant dataSharing planned: No
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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.
Abele Donati, MD principal investigator
Università Politecnica delle Marche
1 site 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 Università Politecnica delle Marche at 1 site in Italy.
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 1 inclusion and 4 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 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Correlation between changes in perfused vessel density and 90 days mortality from ICU admission (time frame: 90 days). The study lists 2 primary outcomes in all. 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 NCT02649088, 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 7 Jan 2016.