Clinical trial NCT05092165: Methylene Blue for the Prevention of Hypotension During Hemodialysis
Official title: Methylene Blue for the Prevention of Hypotension During Hemodialysis: a Randomized Open Label Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acute Kidney Injury
Shock
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Composite Endpoint
timeFrame: 6 hours
Secondary outcomes:
measure: Hypotension
timeFrame: 6 hours
measure: Maximum vasopressor dose
timeFrame: 24 hours
measure: Mortality in the intensive care unit
timeFrame: 60 days
measure: Mortality in the hospital
timeFrame: 60 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Carla Pontes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Flavia R Machado, MD, PhD
role: STUDY_CHAIR
References: