An interventional study of Anisodamine intravenous infusion in Septic Shock, Sepsis and Critical Illness, sponsored by First Affiliated Hospital of Wannan Medical College. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by First Affiliated Hospital of Wannan Medical College · Not applicable, Interventional, and Basic science
Among 88 studies in Shock, Septic with a site in China — 29 open to participants now, 31 under way, 1 of them phase 3. Shock, Septic · China.
Among the 88 studies in Shock, Septic with a site in China, this one is the 52nd largest by planned enrollment of the 61 interventional ones that give a count, is one of 14 that started in 2026, is one of 40 with no phase, reaches primary completion later than 23 of the 30 other live ones, and was the 78th registered.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
Browse Shock, Septic studies →29 of the 88 studies in Shock, Septic with a site in China are open now. Recruiting first, the newest first:
Sir Run Run Shaw Hospital · Sites in China
Ages 18+ · Healthy volunteers
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
Ages 18+
Northern Jiangsu People's Hospital · Sites in China
Ages 18–90
First Affiliated Hospital of Wannan Medical College · Sites in China
Ages 18+
Fan Zeng · Sites in China
Ages 18–85
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 136 Shock, Septic studies recruiting now, 102 (75%) set no upper age limit and 19 (14%) stop at 75 or younger; 12 take children under 18; 13 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
88 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 7 · Phase 3 4 · Phase 4 11
First in 2006; this study’s year is marked. 14 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 79 across 636 interventional studies indexed under Shock, Septic.
Median enrollment 72 across the 61 interventional studies, 148 across the 26 observational. Of the 33 that completed or were terminated, 2 (6%) have results posted.
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2 of 88 have an industry lead sponsor. The 10 most frequent:
First Affiliated Hospital of Wannan Medical College is the lead sponsor of 37 studies on the registry; 34 are open to participants now.
First Affiliated Hospital of Wannan Medical College has 8 studies filed under Shock, Septic — fewer than ten, so there is no comparison to draw.
11 of the studies in Shock, Septic with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07367113Ying WangPeripheral Perfusion Index-guided Fluid Resuscitation for Preventing Acute Skin Failure in Elderly Critically Ill Patients | 2026-12 |
| NCT07760415Xiangya Hospital of Central South UniversityEEG Changes and Cognitive Profiles in Sepsis Patients With Different Inflammatory Phenotypes | 2026-12-12 |
| NCT06692036Beijing Chao Yang HospitalAdaptive Blood Purification for the Treatment of Patients With Septic Shock | 2026-12-31 |
| NCT06990295First Affiliated Hospital of Wannan Medical CollegeFocused Ultrasound Spleen Stimulation and Inflammation in Septic Shock | 2026-12-31 |
| NCT03948048Children's Hospital of Fudan UniversityStudy on the Efficacy and Timing of ECMO Therapy in Children With Refractory Septic Shock | 2026-12-31 |
Add all 11 to your calendar (.ics) → With an account.
Among the 88 studies in Shock, Septic with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Anisodamine intravenous infusion
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.
Also known as: Anisodamine hydrobromide, Ani HBr
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
Time frame: 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.
Time frame: Baseline, 3 hours, and 6 hours after initiation of anisodamine
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From initiation of anisodamine to 6 hours after initiation
ICU Length of Stay
Number of days from ICU admission to ICU discharge
Time frame: 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.
Time frame: 28 days after enrollment
28-Day Mortality
All-cause mortality within 28 days after enrollment
Time frame: 28 days after enrollment
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Dec 2027, 16 months later.
Of 164 non-industry interventional studies with no phase under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's planned 16 months is below that.
Counting every sponsor, half of 172 studies reached it within 25 months; a quarter within 12 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Anisodamine
First Affiliated Hospital of Wannan Medical College