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Papaverine and Sublingual Microcirculation in Septic Shock

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07657741
Lead Sponsor First Affiliated Hospital of Wannan Medical College
Collaborators: The First Affiliated Hospital of Bengbu Medical University
Conditions
(from sponsor)
Septic Shock, Microcirculatory Dysfunction, Sublingual Microcirculation, Hemodynamic Instability
Related terms Shock, Septic
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov