Methylene Blue for the Prevention of Hypotension During Hemodialysis (BLUE)

Federal University of São Paulo

Status and phase: Enrolling; Phase 2

Conditions: Shock; Acute Kidney Injury

Treatments: Other: Control; Drug: Methylene Blue

Study type: Interventional

Funder types: Other

Identifiers

NCT05092165

BLUE

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

Methylene Blue

Active Comparator group

Description:

Methylene blue will be infused during renal replacement therapy

Treatment:

Drug: Methylene Blue

Control

Other group

Description:

usual care

Treatment:

Other: Control