PregnancyNCT02351583
Microcirculatory and Tissue and Cerebral Oxygenation in Preeclampsia and Normal Pregnancy: An Observation Study
An observational study of Pregnancy and Eclampsia, run by University of Virginia at 1 site in United States.
Trial summary
Preeclampsia is a disease of pregnancy affecting 3% to 8% of all pregnancies and is a major cause of maternal and perinatal morbidity and mortality. Characterized by alter placentation with subsequent release of inflammatory mediators leading to a generalized endothelial dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- CytoCam and NIRS Artinis PortaLite with OxySoft softwear
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2015to 1 Jun 2017
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Age 18 years and older females (10 with diagnosis of preeclampsia and 10 with normal pregnancy), planned to deliver at UVA
Who may be able to join
- Age 18 years and older females (10 with diagnosis of preeclampsia and 10 with normal pregnancy),
- planned to deliver at UVA
Who cannot join
- patients with:
- diabetes,
- gestational diabetes,
- gestational hypertension,
- chronic hypertension,
- chorioamniotitis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
Official title: Microcirculatory and Tissue and Cerebral Oxygenation Differences Between Preeclampsia and Normal Pregnancy: An Observation Study
Preeclampsia is a disease of pregnancy affecting 3% to 8% of all pregnancies and is a major cause of maternal and perinatal morbidity and mortality. Characterized by alter placentation with subsequent release of inflammatory mediators leading to a generalized endothelial dysfunction. It is now accepted that endothelial dysfunction heralds the clinical manifestations of preeclampsia.
The side-stream darkfield (SDF) microscopy device emits a 550 nm green light with a depth region of interest of 500 um. Green light is absorbed by the erythrocytes and appears black. SDF is a well-known non-invasive tool that can study the microcirculatory changes. It was used before in many situations especially in sepsis and septic shock patients.
Read more
Near-infra-red spectroscopy (NIRS) device, measures the absorbance of near-infra-red (NIR) light by tissues perfused with oxygenated blood, and is capable of measuring changes in parenchymal volume tissues. It was used before in many situations (including pregnant patients) to reflect the tissue oxygenations.
The investigators are planning to use the SDF and NIRS tools to study the microcirculatory change in preeclamptic subjects and normal pregnant subjects. If these two devices are able to determine any changes this should stand as a baseline for future studies in this field.
Read the detailed description
Study procedures:
- Consented at the time of enrollment in the study, which will be at hospital admission for delivery.
- Demographic data, medical history, obstetrical history, prenatal history and delivery information will be obtained from medical records and the subject
- Proteinuria, Placental weight, BMI, Birth weight and gender, mother smoker or not, clinical parameter of preeclampsia, and severity of preeclampsia, uterine artery Doppler results will be collected from medical records .
- SDF and NIRS application will be done once.
Measurements:
Sidestream dark field (SDF)
The side-stream darkfield camera ( CytoCam) will be put under the subjects tongue for 5-10 minutes. Multiple pictures of the small blood vessels will be taken.
Two fields will be selected that included at least 2 arterioles and 2 venules. Arterioles will be identified as high-flow vessels in which the direction of flow is from larger diameter vessels to smaller diameter vessels, while the reverse will be true for venules. Furthermore, arterioles will be distinguished from venules by the difference in erythrocyte flow velocity, which is substantially higher in arterioles than in venules. At least 2 arterioles and 2 venules will be taken from each captured image sequence to measure the blood vessel diameter.
The diameter of blood vessels will be determined using image processing software specifically designed for analysis of the microcirculation. The diameter of microvessels will be determined by drawing a perpendicular line from one side of the luminal vessel wall to the other at 3 separate locations. The functional capillary index (FCD) and the microvascular flow index (MFI) will be calculated as well. The FCD is defined as the total length of perfused capillaries per mm2. The MFI is used to describe the different flow velocities in venules in each observation field. This is a reproducible and validated index based on a semi-quantitative scoring (0=no flow, 1=intermittent flow, 2=sludging flow, 3=continuous flow and 4=high flow) of flow patterns in large (>50 μm), medium (25-50 μm) and small (10-25 μm, including capillaries) venules. Intermittent flow is characterized by a discontinuous flow pattern of erythrocytes during systolic heart contraction, which halts (or even reverses) during the diastolic phase. In sludging flow, individual erythrocytes have different low continuous velocities and they can be easily distinguished from each other. Continuous flow is characterized by an uninterrupted, uniform laminar flow pattern of erythrocytes that still just can be distinguished from each other. With high flow, the velocity of erythrocytes has exceeded the capture rate of the camera and therefore individual erythrocytes cannot be traced anymore and appear as a black column of cells.
CytoCam product is registered by the FDA with number D186803 Class1 exempt. This product is intended to be used for visualization of micro-circulation in tissue in orifices of the human body which may be non-invasively accessed and cutaneous surfaces.
Near-infra-red spectroscopy (NIRS) Artinis PortaLite with OxySoft softwear Artinis systems has developed a customizable NIRS device that measures tissue oxygenation saturation (StO2) of both muscle and brain tissue. This device can be customized in terms of emitter wavelength (5 are available, all in the NIR range) and configuration (2 emitters each @ 30, 35, and 40 mm from the detector). Critically, unlike most other commercially available NIRS devices for clinical care, the Artinis device allows exportation of the actual absorbance waveforms @ 15 Hz sampling rate. Thus, the Artinis PortaLite with OxySoft softwear will be used for research only, not for clinical care. The NIRS probe will be applied to one of the patient's thenar muscle and over the patient forehead and tissue oxygenation (TOI) will be recorded for 5 minutes.
- Being tested
- CytoCam, NIRS Artinis PortaLite with OxySoft softwear
- Medical subject headings
- Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoCamDevice
The side-stream darkfield camera ( CytoCam) will be put under the subjects tongue for 5-10 minutes. Multiple pictures of the small blood vessels will be taken.
NIRS Artinis PortaLite with OxySoft softwearDevice
. The NIRS probe will be applied to one of the patient's thenar muscle and over the patient forehead and tissue oxygenation (TOI) will be recorded for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| preclampsia | 10 with diagnosis of preeclampsia will be examined with both NIRS and cytocam to obtain data Receives: Device: CytoCam; Device: NIRS Artinis PortaLite with OxySoft softwear | |
| normal pregnancy | 10 with normal pregnancy will be examined with both NIRS and cytocam to obtain data Receives: Device: CytoCam; Device: NIRS Artinis PortaLite with OxySoft softwear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of microcirculatory changes by sidestream darkfield microscopy (SDF)
To assess whether sidestream darkfield microscopy (SDF) and could detect microcirculatory changes in patients who developed preeclampsia versus those who do not.
Measured: Day 1
Tissue oxygenation assessed using Near-infra-red spectroscopy (NIRS)
Near-infra-red spectroscopy (NIRS),
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study start1 Jan 2015
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Why it stopped: equipment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Tiouririne, MD, University of Virginia
- Investigators
- Mohamed Tiouririne, MD, Principal investigator, University of Virginia Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351583
- Sponsor's protocol ID
- 17837
- Status last verified
- Mar 2022
- First submitted
- 20 Jan 2015
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Naljayan MV, Karumanchi SA. New developments in the pathogenesis of preeclampsia. Adv Chronic Kidney Dis. 2013 May;20(3):265-70. doi: 10.1053/j.ackd.2013.02.003.
PubMed 23928392Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet. 2008 Jan 5;371(9606):75-84. doi: 10.1016/S0140-6736(08)60074-4.
PubMed 18177778Khan F, Belch JJ, MacLeod M, Mires G. Changes in endothelial function precede the clinical disease in women in whom preeclampsia develops. Hypertension. 2005 Nov;46(5):1123-8. doi: 10.1161/01.HYP.0000186328.90667.95. Epub 2005 Oct 17.
PubMed 16230524Anim-Nyame N, Gamble J, Sooranna SR, Johnson MR, Sullivan MH, Steer PJ. Evidence of impaired microvascular function in pre-eclampsia: a non-invasive study. Clin Sci (Lond). 2003 Apr;104(4):405-12.
PubMed 12653685Nama V, Manyonda IT, Onwude J, Antonios TF. Structural capillary rarefaction and the onset of preeclampsia. Obstet Gynecol. 2012 May;119(5):967-74. doi: 10.1097/AOG.0b013e31824ea092.
PubMed 22525907Pennings FA, Ince C, Bouma GJ. Continuous real-time visualization of the human cerebral microcirculation during arteriovenous malformation surgery using orthogonal polarization spectral imaging. Neurosurgery. 2006 Jul;59(1):167-71; discussion 167-71. doi: 10.1227/01.NEU.0000219242.92669.3B.
PubMed 16823313Mathura KR, Bouma GJ, Ince C. Abnormal microcirculation in brain tumours during surgery. Lancet. 2001 Nov 17;358(9294):1698-9. doi: 10.1016/S0140-6736(01)06722-8.
PubMed 11728549Perez-Barcena J, Goedhart P, Ibanez J, Brell M, Garcia R, Llinas P, Jimenez C, Ince C. Direct observation of human microcirculation during decompressive craniectomy after stroke. Crit Care Med. 2011 May;39(5):1126-9. doi: 10.1097/CCM.0b013e31820ead5e.
PubMed 21317640Sitina M, Turek Z, Parizkova R, Cerny V. In situ assessment of the brain microcirculation in mechanically-ventilated rabbits using sidestream dark-field (SDF) imaging. Physiol Res. 2011;60(1):75-81. doi: 10.33549/physiolres.931937. Epub 2010 Oct 15.
PubMed 20945959Diedler J, Zweifel C, Budohoski KP, Kasprowicz M, Sorrentino E, Haubrich C, Brady KM, Czosnyka M, Pickard JD, Smielewski P. The limitations of near-infrared spectroscopy to assess cerebrovascular reactivity: the role of slow frequency oscillations. Anesth Analg. 2011 Oct;113(4):849-57. doi: 10.1213/ANE.0b013e3182285dc0. Epub 2011 Aug 4.
PubMed 21821514Yamazaki K, Suzuki K, Itoh H, Muramatsu K, Nagahashi K, Tamura N, Uchida T, Sugihara K, Maeda H, Kanayama N. Cerebral oxygen saturation evaluated by near-infrared time-resolved spectroscopy (TRS) in pregnant women during caesarean section - a promising new method of maternal monitoring. Clin Physiol Funct Imaging. 2013 Mar;33(2):109-16. doi: 10.1111/cpf.12001. Epub 2012 Sep 23.
PubMed 23383688
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcirculatory and Tissue and Cerebral Oxygenation Differences Between Preeclampsia and Normal Pregnancy: An Observation Study
- ClinicalTrials.gov ID
- NCT02351583
- Acronym / sponsor ID
- 17837
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: equipment difficulties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 30 Jan 2015 (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.
Preeclampsia is a disease of pregnancy affecting 3% to 8% of all pregnancies and is a major cause of maternal and perinatal morbidity and mortality. Characterized by alter placentation with subsequent release of inflammatory mediators leading to a generalized endothelial dysfunction. It is now accepted that endothelial dysfunction heralds the clinical manifestations of preeclampsia.
The side-stream darkfield (SDF) microscopy device emits a 550 nm green light with a depth region of interest of 500 um. Green light is absorbed by the erythrocytes and appears black. SDF is a well-known non-invasive tool that can study the microcirculatory changes. It was used before in many situations especially in sepsis and septic shock patients.
Near-infra-red spectroscopy (NIRS) device, measures the absorbance of near-infra-red (NIR) light by tissues perfused with oxygenated blood, and is capable of measuring changes in parenchymal volume tissues. It was used before in many situations (including pregnant patients) to reflect the tissue oxygenations.
The investigators are planning to use the SDF and NIRS tools to study the microcirculatory change in preeclamptic subjects and normal pregnant subjects. If these two devices are able to determine any changes this should stand as a baseline for future studies in this field.
Detailed description
Study procedures:
- Consented at the time of enrollment in the study, which will be at hospital admission for delivery.
- Demographic data, medical history, obstetrical history, prenatal history and delivery information will be obtained from medical records and the subject
- Proteinuria, Placental weight, BMI, Birth weight and gender, mother smoker or not, clinical parameter of preeclampsia, and severity of preeclampsia, uterine artery Doppler results will be collected from medical records .
- SDF and NIRS application will be done once.
Measurements:
Sidestream dark field (SDF)
The side-stream darkfield camera ( CytoCam) will be put under the subjects tongue for 5-10 minutes. Multiple pictures of the small blood vessels will be taken.
Two fields will be selected that included at least 2 arterioles and 2 venules. Arterioles will be identified as high-flow vessels in which the direction of flow is from larger diameter vessels to smaller diameter vessels, while the reverse will be true for venules. Furthermore, arterioles will be distinguished from venules by the difference in erythrocyte flow velocity, which is substantially higher in arterioles than in venules. At least 2 arterioles and 2 venules will be taken from each captured image sequence to measure the blood vessel diameter.
The diameter of blood vessels will be determined using image processing software specifically designed for analysis of the microcirculation. The diameter of microvessels will be determined by drawing a perpendicular line from one side of the luminal vessel wall to the other at 3 separate locations. The functional capillary index (FCD) and the microvascular flow index (MFI) will be calculated as well. The FCD is defined as the total length of perfused capillaries per mm2. The MFI is used to describe the different flow velocities in venules in each observation field. This is a reproducible and validated index based on a semi-quantitative scoring (0=no flow, 1=intermittent flow, 2=sludging flow, 3=continuous flow and 4=high flow) of flow patterns in large (>50 μm), medium (25-50 μm) and small (10-25 μm, including capillaries) venules. Intermittent flow is characterized by a discontinuous flow pattern of erythrocytes during systolic heart contraction, which halts (or even reverses) during the diastolic phase. In sludging flow, individual erythrocytes have different low continuous velocities and they can be easily distinguished from each other. Continuous flow is characterized by an uninterrupted, uniform laminar flow pattern of erythrocytes that still just can be distinguished from each other. With high flow, the velocity of erythrocytes has exceeded the capture rate of the camera and therefore individual erythrocytes cannot be traced anymore and appear as a black column of cells.
CytoCam product is registered by the FDA with number D186803 Class1 exempt. This product is intended to be used for visualization of micro-circulation in tissue in orifices of the human body which may be non-invasively accessed and cutaneous surfaces.
Near-infra-red spectroscopy (NIRS) Artinis PortaLite with OxySoft softwear Artinis systems has developed a customizable NIRS device that measures tissue oxygenation saturation (StO2) of both muscle and brain tissue. This device can be customized in terms of emitter wavelength (5 are available, all in the NIR range) and configuration (2 emitters each @ 30, 35, and 40 mm from the detector). Critically, unlike most other commercially available NIRS devices for clinical care, the Artinis device allows exportation of the actual absorbance waveforms @ 15 Hz sampling rate. Thus, the Artinis PortaLite with OxySoft softwear will be used for research only, not for clinical care. The NIRS probe will be applied to one of the patient's thenar muscle and over the patient forehead and tissue oxygenation (TOI) will be recorded for 5 minutes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preclampsia | – | Device: CytoCam, Device: NIRS Artinis PortaLite with OxySoft softwear10 with diagnosis of preeclampsia will be examined with both NIRS and cytocam to obtain data |
| normal pregnancy | – | Device: CytoCam, Device: NIRS Artinis PortaLite with OxySoft softwear10 with normal pregnancy will be examined with both NIRS and cytocam to obtain data |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Age 18 years and older females (10 with diagnosis of preeclampsia and 10 with normal pregnancy), planned to deliver at UVA
Key inclusion criteria (2 listed)
- Age 18 years and older females (10 with diagnosis of preeclampsia and 10 with normal pregnancy),
- planned to deliver at UVA
Key exclusion criteria (6 listed)
- diabetes,
- gestational diabetes,
- gestational hypertension,
- chronic hypertension,
- chorioamniotitis
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 |
|---|---|---|
| CytoCamThe side-stream darkfield camera ( CytoCam) will be put under the subjects tongue for 5-10 minutes. Multiple pictures of the small blood vessels will be taken. | Device | normal pregnancy, preclampsia |
| NIRS Artinis PortaLite with OxySoft softwear. The NIRS probe will be applied to one of the patient's thenar muscle and over the patient forehead and tissue oxygenation (TOI) will be recorded for 5 minutes. | Device | normal pregnancy, preclampsia |
Primary outcome
Assessment of microcirculatory changes by sidestream darkfield microscopy (SDF)
Time frame: Day 1
To assess whether sidestream darkfield microscopy (SDF) and could detect microcirculatory changes in patients who developed preeclampsia versus those who do not.
Tissue oxygenation assessed using Near-infra-red spectroscopy (NIRS)
Time frame: Day 1
Near-infra-red spectroscopy (NIRS),
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Background: PubMed 23928392Naljayan MV, Karumanchi SA. New developments in the pathogenesis of preeclampsia. Adv Chronic Kidney Dis. 2013 May;20(3):265-70. doi: 10.1053/j.ackd.2013.02.003.
- Background: PubMed 18177778Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet. 2008 Jan 5;371(9606):75-84. doi: 10.1016/S0140-6736(08)60074-4.
- Background: PubMed 16230524Khan F, Belch JJ, MacLeod M, Mires G. Changes in endothelial function precede the clinical disease in women in whom preeclampsia develops. Hypertension. 2005 Nov;46(5):1123-8. doi: 10.1161/01.HYP.0000186328.90667.95. Epub 2005 Oct 17.
- Background: PubMed 12653685Anim-Nyame N, Gamble J, Sooranna SR, Johnson MR, Sullivan MH, Steer PJ. Evidence of impaired microvascular function in pre-eclampsia: a non-invasive study. Clin Sci (Lond). 2003 Apr;104(4):405-12.
- Background: PubMed 22525907Nama V, Manyonda IT, Onwude J, Antonios TF. Structural capillary rarefaction and the onset of preeclampsia. Obstet Gynecol. 2012 May;119(5):967-74. doi: 10.1097/AOG.0b013e31824ea092.
- Background: PubMed 16823313Pennings FA, Ince C, Bouma GJ. Continuous real-time visualization of the human cerebral microcirculation during arteriovenous malformation surgery using orthogonal polarization spectral imaging. Neurosurgery. 2006 Jul;59(1):167-71; discussion 167-71. doi: 10.1227/01.NEU.0000219242.92669.3B.
- Background: PubMed 11728549Mathura KR, Bouma GJ, Ince C. Abnormal microcirculation in brain tumours during surgery. Lancet. 2001 Nov 17;358(9294):1698-9. doi: 10.1016/S0140-6736(01)06722-8.
- Background: PubMed 21317640Perez-Barcena J, Goedhart P, Ibanez J, Brell M, Garcia R, Llinas P, Jimenez C, Ince C. Direct observation of human microcirculation during decompressive craniectomy after stroke. Crit Care Med. 2011 May;39(5):1126-9. doi: 10.1097/CCM.0b013e31820ead5e.
- Background: PubMed 20945959Sitina M, Turek Z, Parizkova R, Cerny V. In situ assessment of the brain microcirculation in mechanically-ventilated rabbits using sidestream dark-field (SDF) imaging. Physiol Res. 2011;60(1):75-81. doi: 10.33549/physiolres.931937. Epub 2010 Oct 15.
- Background: PubMed 21821514Diedler J, Zweifel C, Budohoski KP, Kasprowicz M, Sorrentino E, Haubrich C, Brady KM, Czosnyka M, Pickard JD, Smielewski P. The limitations of near-infrared spectroscopy to assess cerebrovascular reactivity: the role of slow frequency oscillations. Anesth Analg. 2011 Oct;113(4):849-57. doi: 10.1213/ANE.0b013e3182285dc0. Epub 2011 Aug 4.
- Background: PubMed 23383688Yamazaki K, Suzuki K, Itoh H, Muramatsu K, Nagahashi K, Tamura N, Uchida T, Sugihara K, Maeda H, Kanayama N. Cerebral oxygen saturation evaluated by near-infrared time-resolved spectroscopy (TRS) in pregnant women during caesarean section - a promising new method of maternal monitoring. Clin Physiol Funct Imaging. 2013 Mar;33(2):109-16. doi: 10.1111/cpf.12001. Epub 2012 Sep 23.
- 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.
Mohamed Tiouririne, MD principal investigator
University of Virginia Department of Anesthesiology
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 Pregnancy and Eclampsia, run by University of Virginia at 1 site in United States.
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 6 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: withdrawn, as of the sponsor's last update on 24 Mar 2022. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Assessment of microcirculatory changes by sidestream darkfield microscopy (SDF) (time frame: Day 1). 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 NCT02351583, which also lists 11 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 24 Mar 2022.