Methylene Blue for the Prevention of Hypotension During Hemodialysis

NCT05092165 | Completed Phase 2 DMC

• 1 other identifier: BLUE
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 1

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.

Conditions

Intradialytic Hypotension; Acute Kidney Injury; Shock; Intradialytic Hypertension in Hemodialysis Patients

Keywords

methylene blue; intradialytic hypotension; hemodialysis

Outcome Measures

Primary Outcomes (1)

• Composite Endpoint

  The primary outcome will be a composite consisting of any of the following events: (1) initiation of vasopressor therapy or an increase in vasopressor dose by at least 20% from baseline; (2) interruption of the RRT session; (3) interruption of fluid removal at the request of the attending physician at any point during the session.

  6 hours

Secondary Outcomes (7)

• Hypotension

  6 hours

• Maximum vasopressor dose

  24 hours

• Norepinephrine equivalent dose (NEE)

  24 hours

• RRT session fluid balance

  24 hours

• 24-hour fluid balance

  24 hours

Study Arms (2)

Methylene Blue

ACTIVE COMPARATOR

Methylene blue will be infused during renal replacement therapy

Drug: Methylene Blue

Control

OTHER

usual care

Other: Control

Interventions

Methylene Blue DRUG

BLUE group will receive an intravenous infusion of methylene blue. Following a previous study(12), 1 mg/kg of methylene blue 2% diluted in 50 mL of saline solution will be administered as a bolus over 5 minutes, followed by a continuous infusion of 0.1 mg/kg body weight in a total of 250 mL of saline solution throughout the RRT session

Methylene Blue

Control OTHER

Usual care during renal replacement therapy

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years old
• Acute kidney injury or acute-on-chronic kidney disease requiring intermittent renal replacement therapy hemodialysis
• Systolic blood pressure lower than 100 mmHg or use of vasopressor
• Signed informed consent

You may not qualify if:

• Pregnancy
• Life expectancy less than 24 hours
• Exclusive palliative or end-of-life care
• RRT due to hypertensive crisis
• Known allergy to methylene blue
• Known Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Prior participation in the study
• Acute coronary syndrome
• Chronic nitrate oral use

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04038002, Brazil

Location

MeSH Terms

Conditions

Acute Kidney Injury; Shock

Interventions

Methylene Blue

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Carla Pontes, MD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

• Flavia R Machado, MD, PhD

  Federal University of São Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding of healthcare professionals is not feasible due to the distinct visual of methylene blue. However, outcome assessors and statisticians will remain blinded to group allocation to minimize bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Critical Care Department

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 25, 2021
• Study Start: October 21, 2021
• Primary Completion: December 16, 2025
• Study Completion: December 16, 2025
• Last Updated: April 17, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 months after trial is published
• Access Criteria: After aproval by the executive comittee

Locations

BR (1)