NCT04446871 (SHOCKEM-Blue) is a Phase 2, PHASE3 clinical trial of 0.9% sodium chloride in Septic Shock, sponsored by Hospital Civil de Guadalajara.

Who is sponsoring NCT04446871?

NCT04446871 is sponsored by Hospital Civil de Guadalajara.

What drugs are being tested in NCT04446871?

Interventions in NCT04446871: 0.9% sodium chloride, Methylene Blue.

What condition does NCT04446871 study?

NCT04446871 studies Septic Shock.

Is NCT04446871 still recruiting?

NCT04446871 is currently completed. Last updated 4 November 2022.

Last reviewed 2022-11-04 · How we verify

NCT04446871: SHOCKEM-Blue

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Methylene Blue in Early Septic Shock

Completed Phase 2, PHASE3 Last updated 4 November 2022

What this trial tests

Phase 2, PHASE3 trial testing 0.9% sodium chloride in Septic Shock in 91 participants. Completed in 25 January 2021.

Timeline

17 March 2017

Primary endpoint
10 December 2020

25 January 2021

Quick facts

Lead sponsor	Hospital Civil de Guadalajara
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	91
Start date	17 March 2017
Primary completion	10 December 2020
Estimated completion	25 January 2021
Sites	1 location across Mexico

Drugs / interventions tested

0.9% sodium chloride
Methylene Blue (METHYLENE BLUE) — full drug profile →

Conditions studied

Septic Shock — all drugs for Septic Shock →

Sponsor

Hospital Civil de Guadalajara

Who can join

Adults 18 to 80, any sex, with Septic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Septic shock is a subset of sepsis characterized by a decrease in vascular tone, which contributes to impaired regional blood flow distribution, and leads to organic failure. Besides intravenous fluids and adequate antimicrobial therapy, patients with septic shock require vasopressor support, which can lead to many adverse effects, therefore, non-vasopressor agents that can improve hemodynamic status are needed. In this randomized controlled-study, the investigators will address the efficacy and safety of infusion with methylene blue in patients with septic shock.

Publications & conference data

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

Early adjunctive methylene blue in patients with septic shock: a randomized controlled trial.
Ibarra-Estrada M, Kattan E, Aguilera-González P, Sandoval-Plascencia L, et al · · 2023 · cited 61× · PMID 36915146 · DOI 10.1186/s13054-023-04397-7
Endothelial Activation and Microcirculatory Disorders in Sepsis.
Raia L, Zafrani L. · · 2022 · cited 34× · PMID 35721048 · DOI 10.3389/fmed.2022.907992

Verify or expand the search:

Other trials of 0.9% sodium chloride

Trials testing the same drug.

NCT07240987 — Mesenchymal Stem Cells for Chronic Kidney Diseases · Phase 1, PHASE2 · not yet recruiting
NCT06823180 — Hydromorphone Hydrochloride Epidural Preemptive Analgesia for Postoperative Pain After Cesarean Section · Phase 4 · completed
NCT06086431 — Dexamethasone Vs. Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery · Phase 4 · completed
NCT06034366 — the Efficacy of 0.01% Atropine for Near Work-induced Transient Myopia and Myopic Progression · NA · unknown
NCT05811676 — Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Pregnant Women With Placenta Previa · Phase 3 · completed

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 Hospital Civil de Guadalajara trials

Trials by the same sponsor.

NCT07404345 — Low-Dose Apixaban Added to Standard Heparin Lock Versus Heparin Lock Alone to Prevent Tunneled Hemodialysis Catheters Dy · Phase 4 · not yet recruiting
NCT07436130 — Curcumin in Critically Ill Patients With Sepsis · NA · not yet recruiting
NCT07224997 — Trimethoprim-Sulfamethoxazole (TMP/SMX) Prophylaxis After Acute Kidney Injury to Prevent Post-discharge Infections · Phase 2 · not yet recruiting
NCT07205627 — Evaluation of the Diaphragmatic Index Before and After a Pulmonary Rehabilitation Program in Patients With Interstitial · NA · not yet recruiting
NCT07198750 — "Bimodal vs Unimodal High-Intensity Pulsed Electromagnetic Field Therapy in Older Adults With Knee Osteoarthritis" · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04446871 (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 Hospital Civil de Guadalajara
Last refreshed: 4 November 2022

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/NCT04446871.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing