Papaverine and Sublingual Microcirculation in Septic Shock

Starting soon · Not applicable

Conditions studied: Septic Shock, Microcirculatory Dysfunction, Sublingual Microcirculation, Hemodynamic Instability

In brief

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.

Key facts

Study ID

NCT07657741

Run by

First Affiliated Hospital of Wannan Medical College

People needed

20

Starts

2026-08-01

Expected to finish

2027-12-30

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 judged by the investigator to substantially increase the risk of papaverine-related adverse effects.
• Conditions preventing reliable sublingual microcirculatory assessment, including major oral or sublingual lesions, active oral bleeding, inability to access the sublingual area, or poor baseline image quality.
• Pregnancy or lactation.
• Participation in another interventional clinical trial that may affect study outcomes or safety.

Where it is running

• The First Affiliated Hospital of Bengbu Medical University — Bengbu, Anhui, China
• The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College) — Wuhu, Anhui, China

Full record on ClinicalTrials.gov

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