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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 ScvOâ‚‚.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascular Occlusion Test | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Central Venous Oxygen Saturation (ScvOâ‚‚) Level | Central venous oxygen saturation will be measured from a central venous blood gas sample. The ScvOâ‚‚ value obtained at baseline will be recorded. | 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. | Baseline (first 1 hour) |
| Baseline Tissue Oxygen Saturation (stOâ‚‚_baseline) | Tissue oxygen saturation will be measured non-invasively from the thenar eminence using Near-Infrared Spectroscopy (NIRS). The baseline stOâ‚‚ value will be recorded immediately before the vascular occlusion test. | Within 1 hour of enrollment |
| Minimum Tissue Oxygen Saturation During Vascular Occlusion (stOâ‚‚_min) | During the vascular occlusion test (inflation of a cuff to stop arterial inflow), the lowest tissue oxygen saturation (stOâ‚‚_min) recorded from the NIRS probe on the thenar eminence will be measured and recorded. | Within 1 hour of enrollment |
| Maximum Tissue Oxygen Saturation After Reperfusion (stOâ‚‚_max) | After release of the vascular occlusion, the highest tissue oxygen saturation (stOâ‚‚_max) value recorded during reactive hyperemia will be measured and recorded. | Within 1 hour of enrollment |
| Recovery Time (From stOâ‚‚_min to stOâ‚‚_max) | Recovery time will be defined as the time interval between the minimum tissue oxygen saturation (stOâ‚‚_min) during vascular occlusion and the maximum tissue oxygen saturation (stOâ‚‚_max) after cuff release, as measured by NIRS on the thenar eminence. |
| Measure | Description | Time Frame |
|---|---|---|
| 28-Day All-Cause Mortality | Vital status (alive or deceased) will be assessed 28 days after enrollment to determine all-cause mortality. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaziosmanpasa Training Research Hospital | Istanbul | 34255 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| Within 1 hour of enrollment |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |