Septic ShockANISO-MICRONCT07657702
Effects of Anisodamine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock
A study testing Anisodamine intravenous infusion in people with Septic Shock and Sepsis, run by First Affiliated Hospital of Wannan Medical College at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Septic Shock, Sepsis, Critical Illness
- What is being tested?
- Anisodamine intravenous infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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 allergy or hypersensitivity to anisodamine or any component of the study drug.
- Severe or uncontrolled arrhythmia before enrollment, including sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes, uncontrolled supraventricular tachycardia, or atrial fibrillation/flutter with uncontrolled ventricular response.
- Acute coronary syndrome, clinically significant myocardial ischemia, or cardiac arrest before enrollment during the current ICU stay.
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- Severe cardiac dysfunction judged unsuitable for anisodamine by the treating physician, including severe ventricular dysfunction, cardiogenic shock, or need for high-dose inotropic support.
- Conditions interfering with sublingual microcirculatory assessment, including major oral or sublingual lesions, active oral bleeding, inability to access the sublingual area, or poor baseline image quality.
- Immunocompromised status or agranulocytosis, including long-term immunosuppressive therapy, chemotherapy-associated severe neutropenia, or other severe immune suppression judged by the investigator.
- Pregnancy, planned pregnancy, or lactation.
- Participation in another interventional clinical trial that may affect study outcomes or safety.
- Inability to obtain informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
Wuhu, Anhui, 241000
Shengsheng Tao, 86-18315329399, taoshengsheng@yjsyy.com
About this study
Official title: Effects of Anisodamine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock: A Prospective, Multicenter, Single-arm, Open-label, Pilot Physiological Study
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.
Read more
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.
Read the detailed description
Septic shock is characterized by profound circulatory dysfunction involving both the macrocirculation and the microcirculation. Although conventional resuscitation targets such as mean arterial pressure, cardiac output, and serum lactate are widely used, microcirculatory alterations may persist despite apparent stabilization of systemic hemodynamics. Direct evaluation of sublingual microcirculation may therefore provide additional physiological information in patients with septic shock.
Anisodamine is a non-specific muscarinic cholinoceptor antagonist that has been used in China as an adjunctive therapy in septic shock. Previous clinical studies suggest that anisodamine may improve microcirculatory perfusion, reduce lactate levels, and decrease vasopressor requirements in selected patients with septic shock. However, its immediate effects on directly visualized sublingual microcirculation and vascular-waterfall physiology remain insufficiently characterized.
The vascular-waterfall phenomenon refers to the concept that tissue perfusion is influenced not only by arterial and venous pressures but also by the relationship between upstream pressure, critical closing pressure, and mean systemic filling pressure. In septic shock, changes in vascular tone, vasopressor exposure, vascular closing pressure, and stressed blood volume may alter the effective pressure gradient for tissue perfusion. Evaluation of vascular-waterfall variables together with direct sublingual microcirculatory imaging may provide mechanistic insight into the physiological effects of anisodamine beyond conventional macrocirculatory variables.
This is a prospective, multicenter, single-arm, open-label, interventional pilot physiological study conducted in adult intensive care unit patients with septic shock. Patients will be screened after initial hemodynamic optimization. Eligible patients must have septic shock according to Sepsis-3 criteria, ongoing norepinephrine support, invasive mechanical ventilation, and PiCCO-based hemodynamic monitoring before anisodamine initiation. Patients with contraindications to anisodamine, major conditions interfering with sublingual microcirculatory imaging, severe uncontrolled arrhythmia, or expected death or withdrawal of life-sustaining treatment within 24 hours will be excluded.
After informed consent is obtained, baseline measurements will be performed immediately before anisodamine administration. Anisodamine will be given as an intravenous 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 intravenous infusion at 0.02-0.1 mg/kg/hour. The total daily dose will not exceed 200 mg. The maintenance dose may be adjusted by the treating physician according to the patient's microcirculatory status, serum lactate level, capillary refill time, hemodynamics, and adverse effects. Dose reduction, temporary interruption, or discontinuation will be permitted for safety reasons, including clinically significant hypotension, tachycardia, new-onset or worsening arrhythmia, prolonged QT interval, myocardial ischemia, mental status changes, urinary retention, ileus, or other clinically significant adverse events.
Study assessments will be performed at baseline, 3 hours, and 6 hours after initiation of anisodamine. Sublingual microcirculatory imaging will be used to assess microvascular flow index, perfused vessel density, proportion of perfused vessels, and microcirculatory heterogeneity index. Vascular-waterfall related variables will include estimated critical closing pressure, estimated mean systemic filling pressure, and the Pcc-Pmsf gradient. Systemic hemodynamic and perfusion variables, including heart rate, mean arterial pressure, cardiac index, norepinephrine dose, arterial lactate, urine output, capillary refill time, and PiCCO-derived variables, will also be recorded.
Approximately 20 patients will be enrolled to assess feasibility and generate preliminary estimates of physiological changes after anisodamine administration. The main analyses will describe changes from baseline in sublingual microcirculatory and vascular-waterfall parameters over the 6-hour observation period. Safety events, especially tachycardia and arrhythmias, will be summarized descriptively to inform the design of subsequent controlled studies.
- Conditions
- Septic Shock, Sepsis, Critical Illness
- Being tested
- Anisodamine intravenous infusion
- Keywords
- anisodamine, anisodamine hydrobromide, septic shock, sublingual microcirculation, microvascular flow index, vascular waterfall, critical closing pressure, mean systemic filling pressure, Pcc, Pmsf, PiCCO, mechanical ventilation, arrhythmia
- Medical subject headings
- Shock, Septic, Sepsis, Critical Illness, Hemophilia B, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anisodamine intravenous infusionDrug
Also called Anisodamine hydrobromide, Ani HBr
Anisodamine will be administered as an intravenous 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 intravenous infusion at 0.02-0.1 mg/kg/hour. The maximum total daily dose will be 200 mg. The maintenance dose may be adjusted according to microcirculatory status, serum lactate level, capillary refill time, mean arterial pressure, heart rate, PiCCO-derived hemodynamic variables, vasopressor requirement, and adverse effects.
Dose reduction, temporary interruption, or discontinuation is permitted for safety reasons, including clinically significant hypotension, excessive tachycardia, new-onset or worsening arrhythmia, prolonged QT interval, suspected myocardial ischemia, mental status changes, urinary retention, ileus, or other clinically significant adverse events. The actual dose, infusion duration, and reasons for dose adjustment or discontinuation will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Anisodamine arm | Experimental | Adult patients with septic shock receiving invasive mechanical ventilation, norepinephrine support, and PiCCO-based hemodynamic monitoring after initial resuscitation will receive intravenous anisodamine. Sublingual microcirculatory, vascular-waterfall, PiCCO-derived, macrocirculatory, perfusion, and safety variables will be assessed at baseline, 3 hours, and 6 hours after anisodamine initiation. Receives: Drug: Anisodamine intravenous infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pcc-Pmsf Gradient
The vascular-waterfall pressure gradient will be calculated as the difference between estimated critical closing pressure and estimated mean systemic filling pressure. The outcome is the change in Pcc-Pmsf from baseline to 3 and 6 hours after anisodamine initiation
Measured: Baseline, 3 hours, and 6 hours after initiation of anisodamine
Change From Baseline in Sublingual Microvascular Flow Index
Microvascular flow index will be assessed using sublingual microcirculatory imaging. Three to five sublingual video fields will be recorded at each time point, and MFI will be calculated according to standard microcirculatory scoring methods. The outcome is the change in MFI from baseline to 3 and 6 hours after anisodamine initiation.
Measured: Baseline, 3 hours, and 6 hours after initiation of anisodamine
Secondary outcomes (15)
Change From Baseline in Perfused Vessel Density
Perfused vessel density will be measured from sublingual microcirculatory images. The outcome is the change in PVD from baseline to 3 and 6 hours after anisodamine initiation
Measured: Baseline, 3 hours, and 6 hours after initiation of anisodamine
Change From Baseline in Proportion of Perfused Vessels
Proportion of perfused vessels will be measured from sublingual microcirculatory images. The outcome is the change in PPV from baseline to 3 and 6 hours after anisodamine initiation
Measured: Baseline, 3 hours, and 6 hours after initiation of anisodamine
Change From Baseline in Microcirculatory Heterogeneity Index
Microcirculatory heterogeneity index will be calculated from sublingual microcirculatory measurements. The outcome is the change in HI from baseline to 3 and 6 hours after anisodamine initiation
Measured: Baseline, 3 hours, and 6 hours after initiation of anisodamine
Change From Baseline in Estimated Critical Closing Pressure
Estimated critical closing pressure will be calculated using predefined hemodynamic methods based on arterial pressure waveform-derived parameters and PiCCO-based cardiac output measurements. The outcome is the change in Pcc from baseline to 3 and 6 hours after anisodamine initiation.
Measured: Baseline, 3 hours, and 6 hours after initiation of anisodamine
Change From Baseline in Estimated Mean Systemic Filling Pressure
Estimated mean systemic filling pressure will be calculated using predefined hemodynamic methods based on PiCCO-derived cardiac output and systemic vascular resistance-related variables. The outcome is the change in Pmsf from baseline to 3 and 6 hours after anisodamine initiation
Measured: Baseline, 3 hours, and 6 hours after initiation of anisodamine
Change From Baseline in Mean Arterial Pressure
Mean arterial pressure will be recorded from invasive arterial monitoring at each study time point. The outcome is the change in MAP from baseline to 3 and 6 hours after anisodamine initiation
Measured: Baseline, 3 hours, and 6 hours after initiation of anisodamine
Change From Baseline in Cardiac Index
Cardiac index will be measured using PiCCO-based hemodynamic monitoring. The outcome is the change in cardiac index from baseline to 3 and 6 hours after anisodamine initiation
Measured: Baseline, 3 hours, and 6 hours after initiation of anisodamine
Change From Baseline in Norepinephrine Dose
Norepinephrine dose will be recorded in μg/kg/min at each study time point. The outcome is the change in norepinephrine dose from baseline to 3 and 6 hours after anisodamine initiation
Measured: Baseline, 3 hours, and 6 hours after initiation of anisodamine
Change From Baseline in Arterial Lactate
Arterial lactate concentration will be measured according to routine clinical practice. The outcome is the change in lactate from baseline to 6 hours after anisodamine initiation
Measured: Baseline and 6 hours after initiation of anisodamine
Change From Baseline in Capillary Refill Time
Capillary refill time will be assessed according to local clinical practice. The outcome is the change in capillary refill time from baseline to 3 and 6 hours after anisodamine initiation
Measured: Baseline, 3 hours, and 6 hours after initiation of anisodamine
Incidence of New-Onset or Worsening Arrhythmia
New-onset or worsening arrhythmia will be recorded during the observation period. Arrhythmias of interest include atrial fibrillation, atrial flutter, supraventricular tachycardia, frequent ventricular premature beats requiring treatment, ventricular tachycardia, ventricular fibrillation, torsade de pointes, or any arrhythmia requiring treatment modification, antiarrhythmic therapy, cardioversion, or discontinuation of anisodamine
Measured: From initiation of anisodamine to 6 hours after initiation
Incidence of Prespecified Adverse Events
Prespecified adverse events include clinically significant hypotension, excessive tachycardia, new-onset or worsening arrhythmia, prolonged QT interval, suspected myocardial ischemia, escalation of vasopressor or inotropic support, interruption or discontinuation of anisodamine for safety reasons, mental status changes, urinary retention, ileus, cardiac arrest, or other clinically significant events during the observation period
Measured: From initiation of anisodamine to 6 hours after initiation
ICU Length of Stay
Number of days from ICU admission to ICU discharge
Measured: From ICU admission to ICU discharge, assessed up to 28 days after enrollment
Ventilator-Free Days at Day 28
Number of days alive and free from invasive mechanical ventilation within 28 days after enrollment.
Measured: 28 days after enrollment
28-Day Mortality
All-cause mortality within 28 days after enrollment
Measured: 28 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants will receive intravenous anisodamine and undergo repeated physiological assessments before and after treatment.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Bengbu Medical University
- Responsible party
- Principal investigator, Qiancheng Xu, First Affiliated Hospital of Wannan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657702
- Sponsor's protocol ID
- 2026-ICU06
- Acronym
- ANISO-MICRO
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anisodamine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock: A Prospective, Multicenter, Single-arm, Open-label, Pilot Physiological Study
- ClinicalTrials.gov ID
- NCT07657702
- Acronym / sponsor ID
- ANISO-MICRO / 2026-ICU06
- Conditions
- Septic Shock, Sepsis, Critical Illness
- Keywords
- anisodamine, anisodamine hydrobromide, septic shock, sublingual microcirculation, microvascular flow index, vascular waterfall, critical closing pressure, mean systemic filling pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wannan Medical CollegeUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Bengbu Medical University
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Septic shock is characterized by profound circulatory dysfunction involving both the macrocirculation and the microcirculation. Although conventional resuscitation targets such as mean arterial pressure, cardiac output, and serum lactate are widely used, microcirculatory alterations may persist despite apparent stabilization of systemic hemodynamics. Direct evaluation of sublingual microcirculation may therefore provide additional physiological information in patients with septic shock.
Anisodamine is a non-specific muscarinic cholinoceptor antagonist that has been used in China as an adjunctive therapy in septic shock. Previous clinical studies suggest that anisodamine may improve microcirculatory perfusion, reduce lactate levels, and decrease vasopressor requirements in selected patients with septic shock. However, its immediate effects on directly visualized sublingual microcirculation and vascular-waterfall physiology remain insufficiently characterized.
The vascular-waterfall phenomenon refers to the concept that tissue perfusion is influenced not only by arterial and venous pressures but also by the relationship between upstream pressure, critical closing pressure, and mean systemic filling pressure. In septic shock, changes in vascular tone, vasopressor exposure, vascular closing pressure, and stressed blood volume may alter the effective pressure gradient for tissue perfusion. Evaluation of vascular-waterfall variables together with direct sublingual microcirculatory imaging may provide mechanistic insight into the physiological effects of anisodamine beyond conventional macrocirculatory variables.
This is a prospective, multicenter, single-arm, open-label, interventional pilot physiological study conducted in adult intensive care unit patients with septic shock. Patients will be screened after initial hemodynamic optimization. Eligible patients must have septic shock according to Sepsis-3 criteria, ongoing norepinephrine support, invasive mechanical ventilation, and PiCCO-based hemodynamic monitoring before anisodamine initiation. Patients with contraindications to anisodamine, major conditions interfering with sublingual microcirculatory imaging, severe uncontrolled arrhythmia, or expected death or withdrawal of life-sustaining treatment within 24 hours will be excluded.
After informed consent is obtained, baseline measurements will be performed immediately before anisodamine administration. Anisodamine will be given as an intravenous 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 intravenous infusion at 0.02-0.1 mg/kg/hour. The total daily dose will not exceed 200 mg. The maintenance dose may be adjusted by the treating physician according to the patient's microcirculatory status, serum lactate level, capillary refill time, hemodynamics, and adverse effects. Dose reduction, temporary interruption, or discontinuation will be permitted for safety reasons, including clinically significant hypotension, tachycardia, new-onset or worsening arrhythmia, prolonged QT interval, myocardial ischemia, mental status changes, urinary retention, ileus, or other clinically significant adverse events.
Study assessments will be performed at baseline, 3 hours, and 6 hours after initiation of anisodamine. Sublingual microcirculatory imaging will be used to assess microvascular flow index, perfused vessel density, proportion of perfused vessels, and microcirculatory heterogeneity index. Vascular-waterfall related variables will include estimated critical closing pressure, estimated mean systemic filling pressure, and the Pcc-Pmsf gradient. Systemic hemodynamic and perfusion variables, including heart rate, mean arterial pressure, cardiac index, norepinephrine dose, arterial lactate, urine output, capillary refill time, and PiCCO-derived variables, will also be recorded.
Approximately 20 patients will be enrolled to assess feasibility and generate preliminary estimates of physiological changes after anisodamine administration. The main analyses will describe changes from baseline in sublingual microcirculatory and vascular-waterfall parameters over the 6-hour observation period. Safety events, especially tachycardia and arrhythmias, will be summarized descriptively to inform the design of subsequent controlled studies.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will receive intravenous anisodamine and undergo repeated physiological assessments before and after treatment.
| Arm | Type | Receives |
|---|---|---|
| Anisodamine arm | Experimental | Drug: Anisodamine intravenous infusionAdult patients with septic shock receiving invasive mechanical ventilation, norepinephrine support, and PiCCO-based hemodynamic monitoring after initial resuscitation will receive intravenous anisodamine. Sublingual microcirculatory, vascular-waterfall, PiCCO-derived, macrocirculatory, perfusion, and safety variables will be assessed at baseline, 3 hours, and 6 hours after anisodamine initiation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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 allergy or hypersensitivity to anisodamine or any component of the study drug.
- Severe or uncontrolled arrhythmia before enrollment, including sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes, uncontrolled supraventricular tachycardia, or atrial fibrillation/flutter with uncontrolled ventricular response.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anisodamine intravenous infusionAlso: Anisodamine hydrobromide, Ani HBrAnisodamine will be administered as an intravenous 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 intravenous infusion at 0.02-0.1 mg/kg/hour. The maximum total daily dose will be 200 mg. The maintenance dose may be adjusted according to microcirculatory status, serum lactate level, capillary refill time, mean arterial pressure, heart rate, PiCCO-derived hemodynamic variables, vasopressor requirement, and adverse effects. Dose reduction, temporary interruption, or discontinuation is permitted for safety reasons, including clinically significant hypotension, excessive tachycardia, new-onset or worsening arrhythmia, prolonged QT interval, suspected myocardial ischemia, mental status changes, urinary retention, ileus, or other clinically significant adverse events. The actual dose, infusion duration, and reasons for dose adjustment or discontinuation will be recorded. | Drug | Anisodamine arm |
Primary outcome
Change From Baseline in Pcc-Pmsf Gradient
Time frame: Baseline, 3 hours, and 6 hours after initiation of anisodamine
The vascular-waterfall pressure gradient will be calculated as the difference between estimated critical closing pressure and estimated mean systemic filling pressure. The outcome is the change in Pcc-Pmsf from baseline to 3 and 6 hours after anisodamine initiation
Change From Baseline in Sublingual Microvascular Flow Index
Time frame: Baseline, 3 hours, and 6 hours after initiation of anisodamine
Microvascular flow index will be assessed using sublingual microcirculatory imaging. Three to five sublingual video fields will be recorded at each time point, and MFI will be calculated according to standard microcirculatory scoring methods. The outcome is the change in MFI from baseline to 3 and 6 hours after anisodamine initiation.
15 secondary outcomes
Change From Baseline in Perfused Vessel Density
Time frame: Baseline, 3 hours, and 6 hours after initiation of anisodamine
Change From Baseline in Proportion of Perfused Vessels
Time frame: Baseline, 3 hours, and 6 hours after initiation of anisodamine
Change From Baseline in Microcirculatory Heterogeneity Index
Time frame: Baseline, 3 hours, and 6 hours after initiation of anisodamine
Change From Baseline in Estimated Critical Closing Pressure
Time frame: Baseline, 3 hours, and 6 hours after initiation of anisodamine
Change From Baseline in Estimated Mean Systemic Filling Pressure
Time frame: Baseline, 3 hours, and 6 hours after initiation of anisodamine
Change From Baseline in Mean Arterial Pressure
Time frame: Baseline, 3 hours, and 6 hours after initiation of anisodamine
Change From Baseline in Cardiac Index
Time frame: Baseline, 3 hours, and 6 hours after initiation of anisodamine
Change From Baseline in Norepinephrine Dose
Time frame: Baseline, 3 hours, and 6 hours after initiation of anisodamine
Change From Baseline in Arterial Lactate
Time frame: Baseline and 6 hours after initiation of anisodamine
Change From Baseline in Capillary Refill Time
Time frame: Baseline, 3 hours, and 6 hours after initiation of anisodamine
Incidence of New-Onset or Worsening Arrhythmia
Time frame: From initiation of anisodamine to 6 hours after initiation
Incidence of Prespecified Adverse Events
Time frame: From initiation of anisodamine to 6 hours after initiation
ICU Length of Stay
Time frame: From ICU admission to ICU discharge, assessed up to 28 days after enrollment
Ventilator-Free Days at Day 28
Time frame: 28 days after enrollment
28-Day Mortality
Time frame: 28 days after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anisodamine intravenous infusion in people with Septic Shock and Sepsis, run by First Affiliated Hospital of Wannan Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact qiancheng xu (+86-18297529106, qianchengxu@wnmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Pcc-Pmsf Gradient (time frame: Baseline, 3 hours, and 6 hours after initiation of anisodamine). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.