Trials / Completed
CompletedNCT05092165
Methylene Blue for the Prevention of Hypotension During Hemodialysis
Prospective, Randomized, Controlled Trial Assessing the Effects of Methylene Blue for the Prevention of Hypotension During Renal Replacement Therapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 261 (actual)
- Sponsor
- Federal University of São Paulo · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
BLUE is a randomized, multicenter, open-label trial. Patients with high risk of hypotension during RRT will be randomized to receive either methylene blue infusion at a dose of 1 mg/kg as a bolus, followed by continuous infusion of 0.1 mg/kg of body weight in a total of 200 mL of saline solution throughout the dialysis session, or to usual care. The usual care group will not receive any intervention. A total of 260 patients are expected to be randomized in a 1:1 ratio.
Conditions
- Acute Kidney Injury
- Shock
- Intradialytic Hypotension
- Intradialytic Hypertension in Hemodialysis Patients
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Methylene Blue | BLUE group will receive an intravenous infusion of methylene blue. Following a previous study(12), 1 mg/kg of methylene blue 2% diluted in 50 mL of saline solution will be administered as a bolus over 5 minutes, followed by a continuous infusion of 0.1 mg/kg body weight in a total of 250 mL of saline solution throughout the RRT session |
| OTHER | Control | Usual care during renal replacement therapy |
Timeline
- Start date
- 2021-10-21
- Primary completion
- 2025-12-16
- Completion
- 2025-12-16
- First posted
- 2021-10-25
- Last updated
- 2026-04-17
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT05092165. Inclusion in this directory is not an endorsement.