Using Methylene Blue to Prevent Low Blood Pressure During Dialysis

Methylene Blue for the Prevention of Hypotension During Hemodialysis: a Randomized Open Label Trial

This study is testing if methylene blue can help prevent low blood pressure during dialysis for critically ill patients.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 260 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Federal University of São Paulo (other)
• Locations: 1 site (São Paulo)
• Trial ID: NCT05092165 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of methylene blue in preventing hypotension during hemodialysis in critically ill patients. It is a single-center, randomized, non-blind study that aims to determine if methylene blue can improve blood pressure and hemodynamics in patients undergoing renal replacement therapy. Participants will be randomly assigned to receive either methylene blue or standard treatment, with the primary outcome being the incidence of hypotension during dialysis sessions. The study will also assess the need for therapeutic modifications, such as interruptions or increased vasopressor use.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years with acute or chronic kidney injury requiring renal replacement therapy and experiencing low blood pressure or using vasopressors.

Not a fit: Patients who are pregnant, have imminent death, or have specific contraindications such as known allergies to methylene blue will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve blood pressure stability during hemodialysis, enhancing patient safety and outcomes.

How similar studies have performed: While there is limited evidence for the use of methylene blue in critically ill patients, previous studies have suggested its potential benefits in other settings, making this approach novel yet promising.

Eligibility criteria

Inclusion Criteria:

1. Patient or legal representative accepted trial enrollment
2. Age above 18 years
3. Chronic or acute kidney injury in need for renal replacement therapy
4. Blood pressure lower than 100 mmHg or in use of any vasopressor

Exclusion Criteria:

1. Pregnancy
2. Death considered imminent in the next 24 hours
3. Patients not on full code status
4. Hypertensive patients where dialysis was indicated to remove fluids
5. Known allergy to methylene blue
6. Known glucose-6-phosphate deficiency
7. Previously enrolled in the trial
8. Acute coronary Syndrome
9. Domiciliary nitrate use

Where this trial is running

São Paulo

• Federal University of São Paulo — São Paulo, Brazil (RECRUITING)

Study contacts

• Principal investigator: Carla Pontes, MD — Federal University of São Paulo
• Study coordinator: Carla Pontes, MD

Conditions: Acute Kidney Injury, Shock