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Search / Trial NCT05092165

Methylene Blue for the Prevention of Hypotension During Hemodialysis

Launched by FEDERAL UNIVERSITY OF SÃO PAULO · Oct 13, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the use of methylene blue, a medication that may help improve blood pressure during hemodialysis, which is a treatment for people with kidney problems. When patients are critically ill and need this treatment, they sometimes experience low blood pressure, known as hypotension. The goal of the trial is to see if methylene blue can help these patients maintain better blood pressure while undergoing dialysis.

To participate in this trial, patients must be over 18 years old and have either chronic or acute kidney injury that requires dialysis. They should also have low blood pressure (below 100 mmHg) or be receiving medication to help raise their blood pressure. However, certain individuals, such as those who are pregnant or have specific medical conditions, will not be eligible to participate. If enrolled, patients will receive methylene blue during their treatment and will be carefully monitored to see if it helps improve their blood pressure. This trial is currently recruiting participants, and it aims to provide valuable insights into managing blood pressure during dialysis for critically ill patients.

Gender

ALL

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

About Federal University Of São Paulo

The Federal University of São Paulo (Universidade Federal de São Paulo - UNIFESP) is a prestigious institution dedicated to advancing education, research, and healthcare in Brazil. Renowned for its commitment to innovation and excellence, UNIFESP plays a pivotal role in clinical research, focusing on a multidisciplinary approach to improve health outcomes. The university fosters collaboration among researchers, healthcare professionals, and community stakeholders, ensuring that clinical trials conducted under its auspices adhere to rigorous ethical standards and contribute valuable insights to the medical field. With a rich history of academic achievement and a strong emphasis on translational research, UNIFESP is a key player in the development of new therapies and medical interventions.

Locations

São Paulo, , Brazil

Patients applied

0 patients applied

Trial Officials

Carla Pontes, MD

Principal Investigator

Federal University of São Paulo

Flavia R Machado, MD, PhD

Study Chair

Federal University of São Paulo

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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