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Blue dye may keep blood pressure up during kidney dialysis

NCT ID NCT05092165

Disease control Sponsor: Federal University of São Paulo Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether methylene blue, a dye that affects blood vessel function, can prevent dangerous drops in blood pressure during kidney dialysis. It involved 261 critically ill adults with acute kidney injury who needed dialysis. The goal was to see if the treatment could reduce the need for blood pressure medications or interruptions in dialysis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

261 people

The number who actually took part.

Started

Oct 2021

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute kidney injury Shock

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute kidney injury Intradialytic hypertension in hemodialysis patients Intradialytic hypotension Shock

Contacts and locations

Locations

  • Federal University of São Paulo

    São Paulo, São Paulo, 04038002, Brazil

More trials for these conditions

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