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Completed

NCT Number: NCT07312071

Vasopressor Use Improves Macrocirculation, But What Are Its Effects on Microcirculation?

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.

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Key information

Conditions

Septic Shock Hemodynamic Instability Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome Tissue Ischemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpasa Training Research Hospital

Istanbul, 34255, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 28-Day All-Cause Mortality

    Time frame: 28 days

    Vital status (alive or deceased) will be assessed 28 days after enrollment to determine all-cause mortality.

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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