Septic ShockPhase 3NCT06532240
Methylene Blue for the Treatment of Septic Shock
A Phase 3 study testing Methylene Blue in people with Septic Shock, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of methylene blue among adult patients with septic shock. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Methylene Blue
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2024to 24 Oct 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years old or older;
- diagnosis of septic shock within 12 h.
Who cannot join
- recent intake (4-weeks) of selective serotonin re-uptake inhibitors;
- pregnant;
- definitive pulmonary hypertension or chronic pulmonary heart disease;
- known glucose-6 phosphate dehydrogenase (G-6PD) deficiency;
- known allergy to methylene blue, phenothiazines, or food dyes;
- anticipated death from a preexisting disease within 90 days after randomization (as determined by the enrolling physician);
- refusal of the attending staff or patient family;
- participated in other study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Initiation of Methylene Blue for Septic Shock in Adults: A Randomized Clinical Trial
The purpose of this study is to evaluate the efficacy and safety of methylene blue among adult patients with septic shock.
Read the detailed description
Septic Shock is a leading cause of morbidity and mortality in critically ill patients worldwide.
A potential benefit of methylene blue in the treatment of septic shock has recently been described by Estrada. In patients with septic shock, methylene blue initiated within 24 h reduced time to vasopressor discontinuation and increased vasopressor-free days at 28 days. It also reduced length of stay in ICU and hospital without adverse effects.
In this randomized controlled trial, we aim to evaluate the efficacy and safety of methylene blue on septic shock.
- Conditions
- Septic Shock
- Being tested
- Methylene Blue, Placebo
- Keywords
- septic shock, methylene blue, mortality
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene BlueDrug
Also called MB
Methylene Blue 100mg will be diluted in 40ml 5% dextrose solution.The patient will receive Methylene Blue bolus with a dose of 1 mg/kg (Ideal Body Weight) over 30 minutes,followed by 0.25mg/kg/h as a continuous infusion for 6 hours for 5 days or discontinution of norepinephrine or until ICU discharge, whichever occurred first.
PlaceboDrug
Also called 5%GS
An identical volume of 5% dextrose solution from the placebo drug bag will be administered to patients using the same protocol as intervention arm.
| Study group | Role | What they receive |
|---|---|---|
| Methylene Blue | Experimental | Methylene Blue 100mg will be diluted in 40ml 5% dextrose solution. Methylene Blue(1 mg/kg/IBW iv over 30min+0.25mg/kg/h x 6h) x 5-days/ discontinution of norepinephrine /ICU discharge (whichever occurred first). Receives: Drug: Methylene Blue |
| Placebo | Placebo comparator | 5% dextrose solution in a volume to match experimental arm component. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to shock reversal
Time to shock reversal was defined as the time from randomization to shock reversal.Reversal of shock was defined as the maintenance of a systolic blood pressure of at least 90 mmHg without vasopressor support for at least 24 h.
Measured: 90 days after randomization
Secondary outcomes (4)
28-day mortality
All-cause mortality at day 28 after randomization
Measured: 28 days after randomization
90-day mortality
All-cause mortality at day 90 after randomization
Measured: 90 days after randomization
ICU mortality
All-cause mortality at ICU discharge
Measured: 90 days after randomization
Hospital mortality
All-cause mortality at hospital discharge
Measured: 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start5 Aug 2024
- Primary completion24 Oct 2025
- Study completion24 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing-quan Lv, Northern Jiangsu People's Hospital
- Investigators
- Qingquan Lyu, Master, Principal investigator, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532240
- Sponsor's protocol ID
- 2024ky202
- Status last verified
- Feb 2026
- First submitted
- 29 Jul 2024
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiation of Methylene Blue for Septic Shock in Adults: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06532240
- Acronym / sponsor ID
- 2024ky202
- Conditions
- Septic Shock
- Keywords
- septic shock, methylene blue, mortality
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 24 Oct 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of methylene blue among adult patients with septic shock.
Detailed description
Septic Shock is a leading cause of morbidity and mortality in critically ill patients worldwide.
A potential benefit of methylene blue in the treatment of septic shock has recently been described by Estrada. In patients with septic shock, methylene blue initiated within 24 h reduced time to vasopressor discontinuation and increased vasopressor-free days at 28 days. It also reduced length of stay in ICU and hospital without adverse effects.
In this randomized controlled trial, we aim to evaluate the efficacy and safety of methylene blue on septic shock.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylene Blue | Experimental | Drug: Methylene BlueMethylene Blue 100mg will be diluted in 40ml 5% dextrose solution. Methylene Blue(1 mg/kg/IBW iv over 30min+0.25mg/kg/h x 6h) x 5-days/ discontinution of norepinephrine /ICU discharge (whichever occurred first). |
| Placebo | Placebo comparator | Drug: Placebo5% dextrose solution in a volume to match experimental arm component. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18 years old or older;
- diagnosis of septic shock within 12 h.
Key exclusion criteria (8 listed)
- recent intake (4-weeks) of selective serotonin re-uptake inhibitors;
- pregnant;
- definitive pulmonary hypertension or chronic pulmonary heart disease;
- known glucose-6 phosphate dehydrogenase (G-6PD) deficiency;
- known allergy to methylene blue, phenothiazines, or food dyes;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylene BlueAlso: MBMethylene Blue 100mg will be diluted in 40ml 5% dextrose solution.The patient will receive Methylene Blue bolus with a dose of 1 mg/kg (Ideal Body Weight) over 30 minutes,followed by 0.25mg/kg/h as a continuous infusion for 6 hours for 5 days or discontinution of norepinephrine or until ICU discharge, whichever occurred first. | Drug | Methylene Blue |
| PlaceboAlso: 5%GSAn identical volume of 5% dextrose solution from the placebo drug bag will be administered to patients using the same protocol as intervention arm. | Drug | Placebo |
Primary outcome
Time to shock reversal
Time frame: 90 days after randomization
Time to shock reversal was defined as the time from randomization to shock reversal.Reversal of shock was defined as the maintenance of a systolic blood pressure of at least 90 mmHg without vasopressor support for at least 24 h.
4 secondary outcomes
28-day mortality
Time frame: 28 days after randomization
90-day mortality
Time frame: 90 days after randomization
ICU mortality
Time frame: 90 days after randomization
Hospital mortality
Time frame: 90 days after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qingquan Lyu, Master principal investigator
Northern Jiangsu People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylene Blue in people with Septic Shock, run by Northern Jiangsu People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to shock reversal (time frame: 90 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.