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NCT05092165CompletedPhase 2

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

Source: ClinicalTrials.gov · Last updated 17 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
261 (actual)
First submitted
13 Oct 2021
Start date
Oct 2021
Primary completion date
Dec 2025
Lead sponsor
Federal University of São Paulo
NCT number
NCT05092165

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 261
  • From Oct 2021 to the primary completion date, Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior participation in the study

Other illness

  • Known allergy to methylene blue
  • Acute coronary syndrome

Lab values

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

Other

  • Pregnancy
  • Life expectancy less than 24 hours
  • Exclusive palliative or end-of-life care
  • RRT due to hypertensive crisis
  • Chronic nitrate oral use

Who the study is looking for

  • Patients over 18 years old
  • Acute kidney injury or acute-on-chronic kidney disease requiring intermittent renal replacement therapy hemodialysis
  • Systolic blood pressure lower than 100 mmHg or use of vasopressor
  • Signed informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Federal University of Sao Paulo
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.