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Completed

NCT Number: NCT05092165

Methylene Blue for the Prevention of Hypotension During Hemodialysis

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Intradialytic Hypertension in Hemodialysis Patients Intradialytic Hypotension Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Shock Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Federal University of São Paulo

São Paulo, 04038002, Brazil

About this study

BLUE is a randomized, multicenter, open-label trial. Patients with high risk of hypotension during RRT will be randomized to receive either methylene blue infusion at a dose of 1 mg/kg as a bolus, followed by continuous infusion of 0.1 mg/kg of body weight in a total of 200 mL of saline solution throughout the dialysis session, or to usual care. The usual care group will not receive any intervention. A total of 260 patients are expected to be randomized in a 1:1 ratio.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Control

Other

Usual care during renal replacement therapy

Primary outcomes

  1. Composite Endpoint

    Time frame: 6 hours

    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.

Secondary outcomes

  1. Hypotension

    Time frame: 6 hours

    Mean blood pressure below 65 mmHg for at least 5 minutes during renal replacement therapy

  2. Maximum vasopressor dose

    Time frame: 24 hours

    Maximum vasopressor dose, in micro-grams per kilogram per minute used during de first 24 hours

  3. Norepinephrine equivalent dose (NEE)

    Time frame: 24 hours

    The cumulative norepinephrine equivalent dose (NEE)

  4. RRT session fluid balance

    Time frame: 24 hours

    The fluid balance of RTT session

  5. 24-hour fluid balance

    Time frame: 24 hours

    The fluid balance on 24-hour after RTT session

  6. Mortality in the intensive care unit

    Time frame: 60 days

    Death in the intensive care unit

  7. Mortality in the hospital

    Time frame: 60 days

    Death during hospital stay

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Prospective, Randomized, Controlled Trial Assessing the Effects of Methylene Blue for the Prevention of Hypotension During Renal Replacement Therapy

Acronym: BLUE

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 25, 2021
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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