Papaverine and Sublingual Microcirculation in Septic Shock (NCT07657741) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Papaverine and Sublingual Microcirculation in Septic Shock
China20 participantsStarted 2026-08-01
Plain-language summary
This is a prospective, multicenter, single-arm, open-label, pilot physiological study designed to evaluate the effects of intravenous papaverine on sublingual microcirculation and the vascular waterfall phenomenon in adult patients with septic shock.
Eligible patients will have septic shock according to Sepsis-3 criteria, require norepinephrine support after adequate fluid resuscitation, and have PiCCO-based hemodynamic monitoring available before papaverine administration. Papaverine will be administered as an intravenous infusion of 30 mg over 10 minutes, followed by a continuous infusion of 2-5 mg/hour. Sublingual microcirculatory variables, vascular-waterfall-related indices, PiCCO-derived hemodynamic variables, macrocirculatory parameters, tissue perfusion variables, vasopressor dose, and safety outcomes will be assessed before and after papaverine administration.
The study aims to explore whether papaverine can improve microvascular perfusion and reduce microcirculatory flow impairment in septic shock, and to provide preliminary physiological and safety data for future controlled trials.
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.
* Septic shock according to Sepsis-3 criteria, defined as suspected or documented infection requiring vasopressors 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 continuous norepinephrine infusion at enrollment.
* Receiving invasive mechanical ventilation at enrollment, allowing assessment of vascular waterfall-related hemodynamic variables.
* PiCCO-based hemodynamic monitoring, invasive arterial pressure monitoring, and central venous access available before papaverine administration.
* Ability to obtain sublingual microcirculatory images of acceptable quality at baseline.
* 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 planned withdrawal of life-sustaining treatment within 24 hours.
* Known allergy or hypersensitivity to papaverine.
* Severe hemodynamic instability judged unsuitable for papaverine by the treating physician, including refractory hypotension or rapidly escalating vasopressor requirement.
* Clinically significant arrhythmia, high-grade atrioventricular block, acute coronary syndrome, or active myocardial ischemia before enrollment.
* Severe hepatic dysfunction…
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.
1This trial is testing papaverine specifically to improve blood flow in the tiny blood vessels of patients in septic shock — is this something that could be relevant to my or my family member's current situation, and what is the standard treatment being used right now instead?
2The trial is listed as 'not yet recruiting,' which means it hasn't started enrolling patients yet — do you know when it might open, and is there a way to be considered once it does become active?
3Since this study is listed as Phase NA, it's not a traditional phase 1, 2, or 3 trial — can you help me understand what that means for how much is already known about papaverine's safety and effectiveness in septic shock patients?
4The trial is measuring something called the 'sublingual microvascular flow index' and a pressure gradient called Pcc-Pmsf — can you explain what these measurements tell us about how well a patient in septic shock is actually responding to treatment, and why they matter?
5Given that septic shock is a critical and fast-moving condition, how realistic is it to consider a research trial like this one versus focusing entirely on established emergency treatments right now?
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 Sublingual Microvascular Flow Index
Timeframe: Baseline, 3 hours, and 6 hours after initiation of papaverine
2
Change From Baseline in Pcc-Pmsf Gradient
Timeframe: Baseline, 3 hours, and 6 hours after initiation of papaverine
Trial details
NCT IDNCT07657741
SponsorFirst Affiliated Hospital of Wannan Medical College