Vasopressor Use Improves Macrocirculation, But What Are Its Effects on Microcirculation? (NCT07312071) | Clinical Trial Compass
CompletedNot Applicable
Vasopressor Use Improves Macrocirculation, But What Are Its Effects on Microcirculation?
Turkey (Türkiye)30 participantsStarted 2023-04-01
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Central Venous Oxygen Saturation (ScvO₂) Level
Timeframe: Baseline (first 1 hour)
2
Norepinephrine Equivalent Vasopressor Dose
Timeframe: Baseline (first 1 hour)
3
Baseline Tissue Oxygen Saturation (stO₂_baseline)
Timeframe: Within 1 hour of enrollment
4
Minimum Tissue Oxygen Saturation During Vascular Occlusion (stO₂_min)
Timeframe: Within 1 hour of enrollment
5
Maximum Tissue Oxygen Saturation After Reperfusion (stO₂_max)
Timeframe: Within 1 hour of enrollment
6
Recovery Time (From stO₂_min to stO₂_max)
Timeframe: Within 1 hour of enrollment
Trial details
NCT IDNCT07312071
SponsorGaziosmanpasa Research and Education Hospital