Last reviewed · How we verify
NCT04134403: STASIS
Steroids, Thiamine and Ascorbic Acid in Septic Shock
Phase 3 trial testing STASIS in Septic Shock in 80 participants. Status unknown.
1 November 2020
Quick facts
| Lead sponsor | Baqiyatallah Medical Sciences University |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 December 2019 |
| Primary completion | 1 November 2020 |
| Estimated completion | 1 December 2020 |
Drugs / interventions tested
- STASIS — full drug profile →
Conditions studied
- Septic Shock — all drugs for Septic Shock →
Sponsor
Baqiyatallah Medical Sciences University
Who can join
18 and older, any sex, with Septic Shock. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this project is to determine if in patients admitted to the hospital with septic shock (population), does treatment with a bundle including hydrocortisone, thiamine, and ascorbic acid improve in-hospital or 28-day mortality (primary outcomes) or surrogate markers of illness severity including: (1) ICU or hospital length-of-stay, (2) duration of invasive mechanical ventilation, (3) duration of vasopressor administration, (4) incidence and severity of ICU delirium, and (5) illness severity (secondary outcomes).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Corticosteroids for treating sepsis in children and adults.
Annane D, Briegel J, Granton D, Bellissant E, et al · · 2025 · cited 7× · PMID 40470636 · DOI 10.1002/14651858.cd002243.pub5
Verify or expand the search:
- PubMed search for NCT04134403
- 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 Baqiyatallah Medical Sciences University trials
Trials by the same sponsor.
- NCT06369688 — IDEAL SKIIN CARES Bundle to Prevent Pressure Injury · NA · not yet recruiting
- NCT04463420 — Safety and Efficacy of PHR 160 Spray on the Outcomes of Patients With COVID-19 · NA · unknown
- NCT04466280 — Efficacy and Safety of Mucoadhesive Sustained Release, Mucodentol, in Comparison With Hydroxychloroquine to Prevent COVI · NA · withdrawn
- NCT04460092 — Using 32 - Gauge Needles With Lengths of 5 mm and 8 mm on Pain Post-injection, Leak and Blood Glucose · NA · unknown
- NCT04376814 — Favipiravir Plus Hydroxychloroquine and Lopinavir/Ritonavir Plus Hydroxychloroquine in COVID-19 · NA · completed
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 NCT04134403 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 Baqiyatallah Medical Sciences University
- Last refreshed: 22 October 2019
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/NCT04134403.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing