Methylene Blue for the Prevention of Hypotension During Hemodialysis

NCT ID: NCT05092165

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-21
• Study Completion Date: 2025-12-31

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.

Conditions

Acute Kidney Injury; Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Methylene Blue

Methylene blue will be infused during renal replacement therapy

Group Type: ACTIVE_COMPARATOR

Methylene Blue

Intervention Type: DRUG

1 mg per kilogram bolus, followed by 0.1 milligram per kilogram during renal replacement therapy

Control

usual care

Group Type: OTHER

Control

Intervention Type: OTHER

Usual care during renal replacement therapy

Interventions

Methylene Blue

1 mg per kilogram bolus, followed by 0.1 milligram per kilogram during renal replacement therapy

Intervention Type: DRUG

Control

Usual care during renal replacement therapy

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Flavia Ribeiro Machado

Chief of Critical Care Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carla Pontes, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Flavia R Machado, MD, PhD

Role: STUDY_CHAIR

Federal University of São Paulo

Locations

Federal University of São Paulo

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Carla Pontes, MD

Role: CONTACT

pontes4@live.com

+551155764848

Flavia R Machado, MD, PhD

Role: CONTACT

frmachado@unifesp.br

+551155764848 ext. 17018

Facility Contacts

Carla Pontes, MD

Role: primary

pontes4@live.com

Other Identifiers

BLUE

Identifier Type: -

Identifier Source: org_study_id