Methylene Blue for the Prevention of Hypotension During Hemodialysis

Last updated: April 12, 2026
Sponsor: Federal University of São Paulo
Overall Status: Completed

Phase

2

Condition

Circulation Disorders

Kidney Disease

Dizzy/fainting Spells

Treatment

Methylene Blue

Control

Clinical Study ID

NCT05092165
BLUE
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients over 18 years old

  • Acute kidney injury or acute-on-chronic kidney disease requiring intermittent renalreplacement therapy hemodialysis

  • Systolic blood pressure lower than 100 mmHg or use of vasopressor

  • Signed informed consent

Exclusion

Exclusion Criteria:

  • Pregnancy

  • Life expectancy less than 24 hours

  • Exclusive palliative or end-of-life care

  • RRT due to hypertensive crisis

  • Known allergy to methylene blue

  • Known Glucose-6-phosphate dehydrogenase (G6PD) deficiency

  • Prior participation in the study

  • Acute coronary syndrome

  • Chronic nitrate oral use

Study Design

Total Participants: 261
Treatment Group(s): 2
Primary Treatment: Methylene Blue
Phase: 2
Study Start date:
October 21, 2021
Estimated Completion Date:
December 16, 2025

Study 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.

Connect with a study center

  • Federal University of São Paulo

    São Paulo, São Paulo 04038002
    Brazil

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.