CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 355 enrolled
Drug / intervention
anisodaminedrug
Likely dose
anisodamine 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02442440
NCT02442440Phase 2Completed
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Effectiveness of Anisodamine for the Treatment of Critically Ill Patients With Septic Shock: a Randomized Controlled Trial

Jinhua Central Hospital·interventional·Posted May 13, 2015·Updated Sep 29, 2021

In Brief

A Phase 2 clinical trial evaluating anisodamine for Septic Shock. Completed, enrolled 355 participants across 15 sites.

Detailed Summary

Anisodamine has been widely used in China for its pharmacological effect on improving microcirculation during shock. It has been reported that anisodamine is effective in reducing mortality rate in children with meningitis. however, its effectiveness in patients with septic shock has not been systematically investigated. The aim of the study is to investigate the effectiveness of anisodamine in the treatment of patients with septic shock.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeptic Shock
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 13, 2015
Enrollment StartApr 1, 2015
Primary CompletionOct 1, 2020
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 11.1 years ago

Interventions

anisodaminedrug

Anisodamine will be given first as bolus of 10 mg, followed by 0.1-0.5mg/kg/hr. The adjustment of pump infusion rate is largely at the discretion of treating physician, with the aim of improving microcirculation and limit the side effect to a minimum. For example, if serum lactate continues to elevate, the infusion rate can be increased. Discontinuation on severe side effect or recovery of shock (normalized lactate, weaned from vasopressor) or death.