Methylene Blue for the Prevention of Hypotension During Hemodialysis

Phase 2

Recruiting

• Conditions: Shock; Acute Kidney Injury
• Interventions: Other: Control; Drug: Methylene Blue

• Registration Number: NCT05092165
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-10-13
• Study Start: 2021-10-21
• Study First Posted: 2021-10-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-08
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	usual care
Methylene Blue	Methylene Blue	Methylene blue will be infused during renal replacement therapy

Primary Outcome Measures

Name	Time	Method
Composite Endpoint	6 hours	Composite endpoint of: Increase in vasopressor dose in at least 15% of initial dose or interruption of dialysis or reduction in ultrafiltration rate

Secondary Outcome Measures

Name	Time	Method
Hypotension	6 hours	Mean blood pressure below 65 mmHg for at least 5 minutes during renal replacement therapy
Maximum vasopressor dose	24 hours	Maximum vasopressor dose, in micro-grams per kilogram per minute used during de first 24 hours
Mortality in the hospital	60 days	Death during hospital stay
Mortality in the intensive care unit	60 days	Death in the intensive care unit

Trial Locations

Locations (1)

Federal University of São Paulo; 🇧🇷 São Paulo, Brazil