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Methylene Blue for the Prevention of Hypotension During Hemodialysis

NCT05092165 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2026-04-17

No results posted yet for this study

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

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

Interventions

DRUG

Methylene Blue

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

OTHER

Control

Usual care during renal replacement therapy

Sponsors & Collaborators

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Carla Pontes, MD · Federal University of São Paulo

  • Flavia R Machado, MD, PhD · Federal University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-21
Primary Completion
2025-12-16
Completion
2025-12-16

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05092165 on ClinicalTrials.gov