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Could a blue dye help reverse septic shock?

NCT ID NCT06532240

Disease control Sponsor: Northern Jiangsu People's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 used in medicine, can help adults with septic shock recover faster. 88 participants received either methylene blue or a placebo for up to 5 days. The main goal was to see how quickly blood pressure stabilized without other drugs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
methylene blue
What this could lead to
If it works, this could offer a new way to treat septic shock and reduce time on blood pressure support.
What could go wrong
This is a small, completed trial with 88 participants. Results may not apply to all patients, and methylene blue can cause side effects like allergic reactions or interactions with other drugs.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

88 people

The number who actually took part.

Started

Aug 2024

Finished

Oct 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 to 90 years

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: 1. age 18 years old or older; 2. diagnosis of septic shock within 12 h. Exclusion Criteria: 1. recent intake (4-weeks) of selective serotonin re-uptake inhibitors; 2. pregnant; 3. definitive pulmonary hypertension or chronic pulmonary heart disease; 4. known glucose-6 phosphate dehydrogenase (G-6PD) deficiency; 5. known allergy to methylene blue, phenothiazines, or food dyes; 6. anticipated death from a preexisting disease within 90 days after randomization (as determined by the enrolling physician); 7. refusal of the attending staff or patient family; 8. participated in other study.

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Conditions

The condition(s) this trial relates to.

toxic shock syndrome

As listed by the trial registrant

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

Septic shock

Contacts and locations

Locations

  • Northern Jiangsu people's hospital

    Yangzhou, Jiangsu, 225000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.