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NCT02442440: ACIdoSIS

Effectiveness of Anisodamine for the Treatment of Critically Ill Patients With Septic Shock: a Randomized Controlled Trial

Completed Phase 1/Phase 2 Last updated 23 September 2021
What this trial tests

Phase 1/Phase 2 trial testing anisodamine in Septic Shock in 355 participants. Completed in 1 October 2020.

Timeline
1 April 2015
Primary endpoint
1 October 2020
1 October 2020

Quick facts

Lead sponsorJinhua Central Hospital
PhasePhase 1/Phase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment355
Start date1 April 2015
Primary completion1 October 2020
Estimated completion1 October 2020
Sites15 locations across China

Drugs / interventions tested

Conditions studied

Sponsor

Jinhua Central Hospital

Who can join

15 and older, any sex, with Septic Shock. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effectiveness of anisodamine for the treatment of critically ill patients with septic shock: a multicentre randomized controlled trial.
    Yu Y, Zhu C, Hong Y, Chen L, et al · · 2021 · cited 20× · PMID 34579741 · DOI 10.1186/s13054-021-03774-4
  2. A phase III, multicenter randomized controlled trial of neo-adjuvant chemotherapy paclitaxel plus cisplatin versus surgery alone for stage IIA-IIIB esophageal squamous cell carcinoma.
    Zheng Y, Li Y, Liu X, Zhang R, et al · · 2017 · cited 11× · PMID 28203424 · DOI 10.21037/jtd.2017.01.44
  3. Effectiveness of anisodamine for the treatment of critically ill patients with septic shock (ACIdoSIS study): study protocol for randomized controlled trial.
    Zhang Z, Zhou J, Shang Y, Wang X, et al · · 2015 · cited 4× · PMID 26605292 · DOI 10.3978/j.issn.2305-5839.2015.10.03

Verify or expand the search:

Other recruiting trials for Septic Shock

Currently open trials in the same condition.

Other Jinhua Central Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02442440.

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