Septic ShockNCT07312071
Vasopressor Use Improves Macrocirculation, But What Are Its Effects on Microcirculation?
A study testing Vascular Occlusion Test in people with Septic Shock and Sepsis, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
To manage the treatment in the intensive care unit for patients with septic shock, central venous oxygen saturation (scvO2) is used as a macrocirculatory indicator, with a target value of 70% or higher being recommended. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Sepsis, Tissue Ischemia
- What is being tested?
- Vascular Occlusion Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 30 Sep 2023
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 years or older
- Diagnosis of septic shock
- Receiving vasopressor and mechanical ventilation therapy
- Presence of a central venous catheter that allows ScvO₂ sampling
- Ability to obtain tissue oxygenation (stO₂) measurements using a NIRS probe placed on the thenar eminence
- Written informed consent obtained from patient or legal representative
Who cannot join
- Local infection, wound, or skin lesion at the planned NIRS probe application site
- Mean arterial pressure (MAP) < 60 mmHg despite vasopressor therapy
- Pregnancy
- Inability to safely perform the vascular occlusion test (as judged by treating clinician)
- Any condition preventing safe blood sampling or reliable stO₂ measurement
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Training Research Hospital
Istanbul, 34255
About this study
To manage the treatment in the intensive care unit for patients with septic shock, central venous oxygen saturation (scvO2) is used as a macrocirculatory indicator, with a target value of 70% or higher being recommended. Tissue oxygenation (stO2) measurement can be implemented to assess the microcirculation in these patients, but a specific target value has not been established yet. The investigators believe that guiding the treatment of septic shock patients based on the measurement of microcirculation using stO2 and evaluating its correlation with scvO2 can reduce mortality.
This study aims to investigate the independent impact of high-dose norepinephrine on microvascular reactivity assessed by NIRS-VOT in patients with septic shock, while also examining how these microcirculatory indices relate to the macrocirculatory marker ScvO₂.
- Conditions
- Septic Shock, Sepsis, Tissue Ischemia, Hemodynamic Instability
- Being tested
- Vascular Occlusion Test
- Keywords
- Tissue oxygenation, Vazopressor, Septic Shock, Sepsis, microcirculation
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular Occlusion TestDiagnostic test
The vascular occlusion test is a procedure performed to assess the vascular status and perfusion of a limb. It involves temporarily stopping blood flow to the limb by applying a blood pressure cuff.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Other | The study will include adult patients aged 18 and above who are receiving vasopressor therapy due to septic shock in the intensive care unit. Receives: Diagnostic Test: Vascular Occlusion Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Venous Oxygen Saturation (ScvO₂) Level
Central venous oxygen saturation will be measured from a central venous blood gas sample. The ScvO₂ value obtained at baseline will be recorded.
Measured: Baseline (first 1 hour)
Norepinephrine Equivalent Vasopressor Dose
The vasopressor requirement will be expressed as the norepinephrine equivalent dose (NEq), calculated in µg/kg/min.
Measured: Baseline (first 1 hour)
Baseline Tissue Oxygen Saturation (stO₂_baseline)
Tissue oxygen saturation will be measured non-invasively from the thenar eminence using Near-Infrared Spectroscopy (NIRS). The baseline stO₂ value will be recorded immediately before the vascular occlusion test.
Measured: Within 1 hour of enrollment
Minimum Tissue Oxygen Saturation During Vascular Occlusion (stO₂_min)
During the vascular occlusion test (inflation of a cuff to stop arterial inflow), the lowest tissue oxygen saturation (stO₂_min) recorded from the NIRS probe on the thenar eminence will be measured and recorded.
Measured: Within 1 hour of enrollment
Maximum Tissue Oxygen Saturation After Reperfusion (stO₂_max)
After release of the vascular occlusion, the highest tissue oxygen saturation (stO₂_max) value recorded during reactive hyperemia will be measured and recorded.
Measured: Within 1 hour of enrollment
Recovery Time (From stO₂_min to stO₂_max)
Recovery time will be defined as the time interval between the minimum tissue oxygen saturation (stO₂_min) during vascular occlusion and the maximum tissue oxygen saturation (stO₂_max) after cuff release, as measured by NIRS on the thenar eminence.
Measured: Within 1 hour of enrollment
Secondary outcomes (1)
28-Day All-Cause Mortality
Vital status (alive or deceased) will be assessed 28 days after enrollment to determine all-cause mortality.
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 posted31 Dec 2025
- Study start1 Apr 2023
- Primary completion31 Aug 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Oguz Özakın, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312071
- Sponsor's protocol ID
- 1234
- Status last verified
- Dec 2025
- First submitted
- 7 Jul 2023
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ozakin O, Sehirlioglu S, Ozakin FC, Moralar DG, Dinc V. Effects of vasopressor dose on microcirculation despite preserved macrohemodynamic targets in septic shock: a prospective observational study. J Crit Care. 2026 Sep 24;97:155762. doi: 10.1016/j.jcrc.2026.155762. Online ahead of print.
PubMed 42790104
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasopressor Use Improves Macrocirculation, But What Are Its Effects on Microcirculation?
- ClinicalTrials.gov ID
- NCT07312071
- Acronym / sponsor ID
- 1234
- Conditions
- Septic Shock, Sepsis, Tissue Ischemia, Hemodynamic Instability
- Keywords
- Tissue oxygenation, Vazopressor, Septic Shock, Sepsis, microcirculation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 31 Dec 2025 (actual)
- 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.
To manage the treatment in the intensive care unit for patients with septic shock, central venous oxygen saturation (scvO2) is used as a macrocirculatory indicator, with a target value of 70% or higher being recommended. Tissue oxygenation (stO2) measurement can be implemented to assess the microcirculation in these patients, but a specific target value has not been established yet. The investigators believe that guiding the treatment of septic shock patients based on the measurement of microcirculation using stO2 and evaluating its correlation with scvO2 can reduce mortality.
This study aims to investigate the independent impact of high-dose norepinephrine on microvascular reactivity assessed by NIRS-VOT in patients with septic shock, while also examining how these microcirculatory indices relate to the macrocirculatory marker ScvO₂.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Other | Diagnostic Test: Vascular Occlusion TestThe study will include adult patients aged 18 and above who are receiving vasopressor therapy due to septic shock in the intensive care unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Diagnosis of septic shock
- Receiving vasopressor and mechanical ventilation therapy
- Presence of a central venous catheter that allows ScvO₂ sampling
- Ability to obtain tissue oxygenation (stO₂) measurements using a NIRS probe placed on the thenar eminence
Key exclusion criteria (5 listed)
- Local infection, wound, or skin lesion at the planned NIRS probe application site
- Mean arterial pressure (MAP) < 60 mmHg despite vasopressor therapy
- Pregnancy
- Inability to safely perform the vascular occlusion test (as judged by treating clinician)
- Any condition preventing safe blood sampling or reliable stO₂ measurement
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 |
|---|---|---|
| Vascular Occlusion TestThe vascular occlusion test is a procedure performed to assess the vascular status and perfusion of a limb. It involves temporarily stopping blood flow to the limb by applying a blood pressure cuff. | Diagnostic test | Study group |
Primary outcome
Central Venous Oxygen Saturation (ScvO₂) Level
Time frame: Baseline (first 1 hour)
Central venous oxygen saturation will be measured from a central venous blood gas sample. The ScvO₂ value obtained at baseline will be recorded.
Norepinephrine Equivalent Vasopressor Dose
Time frame: Baseline (first 1 hour)
The vasopressor requirement will be expressed as the norepinephrine equivalent dose (NEq), calculated in µg/kg/min.
Baseline Tissue Oxygen Saturation (stO₂_baseline)
Time frame: Within 1 hour of enrollment
Tissue oxygen saturation will be measured non-invasively from the thenar eminence using Near-Infrared Spectroscopy (NIRS). The baseline stO₂ value will be recorded immediately before the vascular occlusion test.
Minimum Tissue Oxygen Saturation During Vascular Occlusion (stO₂_min)
Time frame: Within 1 hour of enrollment
During the vascular occlusion test (inflation of a cuff to stop arterial inflow), the lowest tissue oxygen saturation (stO₂_min) recorded from the NIRS probe on the thenar eminence will be measured and recorded.
Maximum Tissue Oxygen Saturation After Reperfusion (stO₂_max)
Time frame: Within 1 hour of enrollment
After release of the vascular occlusion, the highest tissue oxygen saturation (stO₂_max) value recorded during reactive hyperemia will be measured and recorded.
Recovery Time (From stO₂_min to stO₂_max)
Time frame: Within 1 hour of enrollment
Recovery time will be defined as the time interval between the minimum tissue oxygen saturation (stO₂_min) during vascular occlusion and the maximum tissue oxygen saturation (stO₂_max) after cuff release, as measured by NIRS on the thenar eminence.
1 secondary outcome
28-Day All-Cause Mortality
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 31 Dec 2025.
- Derived from this study: PubMed 42790104Ozakin O, Sehirlioglu S, Ozakin FC, Moralar DG, Dinc V. Effects of vasopressor dose on microcirculation despite preserved macrohemodynamic targets in septic shock: a prospective observational study. J Crit Care. 2026 Sep 24;97:155762. doi: 10.1016/j.jcrc.2026.155762. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascular Occlusion Test in people with Septic Shock and Sepsis, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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 31 Dec 2025. 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 Turkey (Türkiye). 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?
Central Venous Oxygen Saturation (ScvO₂) Level (time frame: Baseline (first 1 hour)). The study lists 6 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 NCT07312071, which also lists 1 linked publication.
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 31 Dec 2025.