Effects of Dexmedetomidine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Pa… (NCT07657715) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effects of Dexmedetomidine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock
China20 participantsStarted 2026-08-01
Plain-language summary
This prospective, multicenter, single-arm, open-label interventional pilot study aims to evaluate the short-term physiological effects of intravenous dexmedetomidine on sublingual microcirculation and vascular-waterfall parameters in adult patients with septic shock.
Eligible patients will have septic shock according to Sepsis-3 criteria, require norepinephrine support after adequate fluid resuscitation, receive invasive mechanical ventilation, and have PiCCO-based hemodynamic monitoring available before dexmedetomidine initiation. After baseline assessment, participants will receive intravenous dexmedetomidine according to the study protocol. Dexmedetomidine will be administered as a continuous intravenous infusion at 0.2-0.7 µg/kg/hour without a loading dose. The infusion rate may be adjusted according to the target sedation level, hemodynamic status, and adverse effects.
Sublingual microcirculatory variables, including microvascular flow index, perfused vessel density, proportion of perfused vessels, and heterogeneity index, as well as vascular-waterfall parameters, including estimated critical closing pressure, estimated mean systemic filling pressure, and the Pcc-Pmsf gradient, will be measured at baseline, 3 hours, and 6 hours after initiation of dexmedetomidine. Systemic hemodynamic, perfusion, vasopressor, PiCCO-derived, sedation-related, and safety outcomes will also be collected.
The primary objective is to characterize immediate changes in sublingual microcirculation and vascular-waterfall physiology after dexmedetomidine administration and to provide preliminary data for future controlled studies.
Who can participate
Age range
18 Years – 85 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 18-85 years.
* Diagnosis of septic shock according to Sepsis-3 criteria, defined as suspected or documented infection with vasopressor requirement to maintain mean arterial pressure ≥65 mmHg and serum lactate \>2 mmol/L after adequate fluid resuscitation.
* Enrollment within 24 hours after diagnosis of septic shock in the ICU.
* Receiving invasive mechanical ventilation.
* Receiving continuous intravenous sedative and/or analgesic therapy other than dexmedetomidine before enrollment, with a clinical decision to add dexmedetomidine for sedation management.
* Continuous norepinephrine infusion at enrollment.
* PiCCO catheter in place and PiCCO-based hemodynamic monitoring available before dexmedetomidine initiation.
* Written informed consent obtained from the patient or legally authorized representative.
Exclusion Criteria:
* Shock primarily caused by non-septic etiologies, including cardiogenic, hypovolemic, obstructive, hemorrhagic, or anaphylactic shock.
* Expected death or withdrawal of life-sustaining treatment within 24 hours.
* Known allergy or hypersensitivity to dexmedetomidine.
* Severe bradycardia or clinically significant conduction abnormality before enrollment, including heart rate \<50 beats/min, second-degree or third-degree atrioventricular block, sick sinus syndrome, or other conduction abnormality without a functioning pacemaker.
* Severe uncontrolled arrhythmia, acute coronary syndrome, or clinically significant myocardial ische…
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.
1My loved one is in the ICU with septic shock — is this trial something worth discussing with the care team, given that it's not yet recruiting and we may not have the luxury of time to wait?
2This trial is studying how dexmedetomidine affects tiny blood vessels and blood flow patterns in septic shock — can you explain whether improving microcirculation is something that could matter for my family member's specific situation?
3Since this trial doesn't have a listed phase, what does that mean for how much is already known about whether dexmedetomidine is safe to use in critically ill septic shock patients, and is it already used in standard care?
4The trial is measuring something called the Pcc-Pmsf gradient and a microvascular flow index — can you help me understand what those measurements tell us about how sick someone is, and whether being in this study would add extra procedures or risks on top of what's already happening in the ICU?
5Are there standard treatments or other studies available right now that we should consider first, rather than waiting for this trial to open to enrollment?
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
Change From Baseline in Pcc-Pmsf Gradient
Timeframe: Baseline, 3 hours, and 6 hours after initiation of dexmedetomidine
2
Change From Baseline in Sublingual Microvascular Flow Index
Timeframe: Baseline, 3 hours, and 6 hours after initiation of dexmedetomidine
Trial details
NCT IDNCT07657715
SponsorFirst Affiliated Hospital of Wannan Medical College