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NCT02442440: ACIdoSIS
Effectiveness of Anisodamine for the Treatment of Critically Ill Patients With Septic Shock: a Randomized Controlled Trial
Phase 1/Phase 2 trial testing anisodamine in Septic Shock in 355 participants. Completed in 1 October 2020.
1 October 2020
Quick facts
| Lead sponsor | Jinhua Central Hospital |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 355 |
| Start date | 1 April 2015 |
| Primary completion | 1 October 2020 |
| Estimated completion | 1 October 2020 |
| Sites | 15 locations across China |
Drugs / interventions tested
- anisodamine — full drug profile →
Conditions studied
- Septic Shock — all drugs for Septic Shock →
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.
-
hospital mortality
Time frame: from ICU admission to hospital discharge (participants will be followed for the duration of hospital stay, an expected average of 28 days)
the outcome will be assessed by using proportion of patients died, and relative risk will be reported.
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):
-
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 -
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 -
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:
- PubMed search for NCT02442440
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Septic Shock
Currently open trials in the same condition.
- NCT07179276 — Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock · NA · recruiting
- NCT07383103 — Hydrocortisone and Fludrocortisone for the Treatment of Septic Shock · Phase 4 · recruiting
- NCT07419802 — OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study · recruiting
- NCT07264543 — Early Methylene Blue in the Microhemodynamics of Septic Patients · Phase 2, PHASE3 · recruiting
- NCT04855786 — External Drainage of Thoracic Duct Lymph to Reduce Inflammatory Cytokines in Septic Shock Patients · NA · recruiting
Other Jinhua Central Hospital trials
Trials by the same sponsor.
- NCT06769685 — TPO Combined With TPORA for Solid Tumors Effectiveness of cTit Above Degree II · enrolling by invitation
- NCT06204094 — Node-sparing Radiotherapy Combined with Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02442440 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jinhua Central Hospital
- Last refreshed: 23 September 2021
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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