Last updated 9 months ago

Methylene Blue for the Prevention of Hypotension During Hemodialysis

260 patients around the world
Available in Brazil
This is a single-center, randomized, non-blind study, with a intention-to-treat analysis, aiming to evaluate whether the use of methylene blue reduces the incidence of hypotension during hemodialysis, resulting in a reduction in the need for therapeutic modifications during the session, defined as interruption session, reduced fluid losses and increased need for vasopressors. Patients will be randomized using RedCap platform in variable blocks of 4-6, stratified by center in a 1:1 ratio and by previous use of vasopressors, into two groups, intervention and usual treatment. Access to randomization will be available 24 hours, 7 days a week. Patients on intermittent renal replacement therapy will be selected to receive or not methylene blue at a bolus dose of 1 mg/kg, followed by a continuous infusion of 0.1 mg/kg of body weight in a total of 200 ml of solution. saline throughout the dialysis session. The usual care group will not receive any intervention.
Federal University of São Paulo
1Research sites
260Patients around the world

This study is for people with

Renal disease
Acute kidney disease
Chronic kidney disease

Requirements for the patient

From 18 Years
All Gender

Medical requirements

Patient or legal representative accepted trial enrollment.
Age above 18 years.
Chronic or acute kidney injury in need for renal replacement therapy.
Blood pressure lower than 100 mmHg or in use of any vasopressor.
Pregnancy.
Death considered imminent in the next 24 hours.
Patients not on full code status.
Hypertensive patients where dialysis was indicated to remove fluids.
Known allergy to methylene blue.
Known glucose-6-phosphate deficiency.
Previously enrolled in the trial.
Acute coronary syndrome.
Domiciliary nitrate use.

Sites

Universidad Federal de São Paulo - Unifesp
Recruiting
R. Sena Madureira, 1500 - Vila Clementino, São Paulo - SP, 04021-001
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