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NCT05092165: BLUE
Methylene Blue for the Prevention of Hypotension During Hemodialysis
Phase 2 trial testing Methylene Blue in Acute Kidney Injury in 261 participants. Completed in 16 December 2025.
16 December 2025
Quick facts
| Lead sponsor | Federal University of São Paulo |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 261 |
| Start date | 21 October 2021 |
| Primary completion | 16 December 2025 |
| Estimated completion | 16 December 2025 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Methylene Blue (METHYLENE BLUE) — full drug profile →
- Control
Conditions studied
- Acute Kidney Injury — all drugs for Acute Kidney Injury →
- Shock — all drugs for Shock →
- Intradialytic Hypotension — all drugs for Intradialytic Hypotension →
- Intradialytic Hypertension in Hemodialysis Patients — all drugs for Intradialytic Hypertension in Hemodialysis Patients →
Sponsor
Federal University of São Paulo
Who can join
18 and older, any sex, with Acute Kidney Injury or Shock. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Hypotension is a common complication of intermittent renal replacement therapy. Methylene blue, an inhibitor of nitric oxide synthesis, has been suggested to improve hemodynamics during renal replacement therapy in ambulatory patients, but evidence is lacking for critically ill patients. This trial will assess whether methylene blue can improve hemodynamics and blood pressure for patients with shock requiring renal replacement therapy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05092165
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Methylene Blue
Trials testing the same drug.
- NCT06052956 — Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses · Phase 2 · not yet recruiting
- NCT07494773 — Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection · Phase 1, PHASE2 · not yet recruiting
- NCT07040540 — Hemodynamic Effects of Intradermal Methylene Blue During Breast Surgery Under General Anesthesia · completed
- NCT07169487 — Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study · Phase 1 · recruiting
- NCT06900140 — Adjunctive Methylene Blue in Septic Shock · Phase 3 · completed
Other recruiting trials for Acute Kidney Injury
Currently open trials in the same condition.
- NCT07273838 — Sodium-Glucose Cotransporter-2 Inhibitor for Patients With Acute Cardiorenal Syndrome · Phase 2 · recruiting
- NCT07262320 — Epidemiology and Processes of Care for Renal Replacement Therapy in Acute Kidney Injury in Latin America · recruiting
- NCT07351149 — Postoperative Acute Kidney Injury in Children Undergoing Major Non-cardiac Surgery · recruiting
- NCT07215702 — A Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kid · Phase 2 · recruiting
- NCT06654193 — Allogeneic HB-adMSCs vs Placebo for the Treatment of Acute Kidney Injury · Phase 1, PHASE2 · recruiting
Other Federal University of São Paulo trials
Trials by the same sponsor.
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- NCT06805656 — Multi Interventional Approaches to Mitigate HIV Reservoirs Aiming the Sustained HIV Remission Without Antiretrovirals · Phase 2 · not yet recruiting
- NCT06970964 — Fermented Milk Drink With Lacticaseibacillus Paracasei Strain Shirota Helps Triathletes With Cold-Like Symptoms Before a · NA · completed
- NCT06905860 — Intra-articular Infiltration of Platelet-Rich Fibrin vs Corticosteroid in Mild to Moderate Knee Osteoarthritis · Phase 4 · not yet recruiting
- NCT06829992 — Effects of Applying Kinesio Tapping on Primary Dysmenorrhea in Football Players · 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 NCT05092165 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Federal University of São Paulo
- Last refreshed: 17 April 2026
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/NCT05092165.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing