Effects of Anisodamine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patien… (NCT07657702) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effects of Anisodamine 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 anisodamine on sublingual microcirculation and vascular-waterfall parameters in adult patients with septic shock.
Eligible patients will have septic shock according to Sepsis-3 criteria, will require norepinephrine support after adequate fluid resuscitation, and will be receiving invasive mechanical ventilation and PiCCO-based hemodynamic monitoring. After baseline assessment, participants will receive intravenous anisodamine according to the study protocol. Anisodamine will be administered as a loading dose of 0.5 mg/kg within 3 minutes, with a minimum dose of 20 mg and a maximum dose of 40 mg, followed by continuous infusion at 0.02-0.1 mg/kg/hour, with a maximum total daily dose of 200 mg.
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 anisodamine. Systemic hemodynamic, perfusion, vasopressor, PiCCO-derived variables, and safety outcomes will also be collected.
The primary objective is to characterize immediate changes in sublingual microcirculation and vascular-waterfall physiology after anisodamine 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 or within 24 hours after ICU admission for septic shock.
* Receiving invasive mechanical ventilation at the time of enrollment.
* PiCCO catheter in place and PiCCO-based hemodynamic monitoring available before anisodamine initiation.
* Continuous norepinephrine infusion at enrollment.
* Adequate initial fluid resuscitation and hemodynamic optimization as judged by the treating physician, with volume status assessed by dynamic indices, echocardiography, or PiCCO-derived variables.
* 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 mainly 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 contraindications to anisodamine or anticholinergic therapy, including glaucoma, acute phase of intracranial hemorrhage, elevated intracranial pressure, untreated bowel obstruction, or prostatic enlargement without urinary catheterization.
* Known al…
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 studying a drug called anisodamine in septic shock — is this something my care team has considered, and would I even be a candidate to discuss once this trial opens for enrollment?
2The trial is listed as 'not yet recruiting' — if my situation is urgent right now, are there any currently active studies or treatments my team could consider in the meantime?
3The study is measuring something called the 'vascular waterfall phenomenon' and microcirculation in tiny blood vessels under the tongue — can you explain in plain terms what these measurements tell us about what's happening in septic shock, and why they matter for my care?
4Since this trial doesn't have a traditional phase number listed, what does that mean for how much is already known about anisodamine's safety and effectiveness in people with septic shock?
5If this trial does open and I'm eligible, how would participating actually work in a critical care setting — would I or my family need to make decisions very quickly, and what rights would we have to stop participation if something changes?
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 anisodamine
2
Change From Baseline in Sublingual Microvascular Flow Index
Timeframe: Baseline, 3 hours, and 6 hours after initiation of anisodamine
Trial details
NCT IDNCT07657702
SponsorFirst Affiliated Hospital of Wannan Medical College