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Early Use of Methylene Blue in Septic Shock

Early Use of Methylene Blue in Septic Shock

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128808
Enrollment
Unknown
Registered
2026-07-27
Start date
2025-08-05
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic shock

Interventions

Methylene blue group:Combined use of methylene blue
Control Group:Guidelines for conventional treatment

Sponsors

Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18 years old - 80 years old; 2. Transferred to the ICU and met the definition of sepsis 3.0 (septic shock) within 24 hours (confirmed sepsis, persistent hypotension occurred, and vasopressor drugs were still needed to maintain mean arterial pressure (MAP) >= 65 mmHg and blood lactate concentration > 2 mmol/L after adequate volume resuscitation)

Exclusion criteria

Exclusion criteria: 1. Patients who already had AKI or were diagnosed with CKD stage 4-5 upon admission to the ICU; 2. Patients who had used norepinephrine for more than 24 hours; 3. Patients who died within 48 hours; 4. Patients who had undergone kidney or liver transplantation; 5. Pregnant or lactating women; 6. Patients with known glucose-6-phosphate dehydrogenase deficiency; 7. Patients with hemorrhagic, obstructive or hypovolemic shock; 8. Patients with severe burns; 9. Patients allergic to methylene blue, phenothiazine drugs or food dyes; 10. Patients who had recently taken selective serotonin reuptake inhibitors; 11. Patients with pulmonary hypertension, right-to-left shunt, increased right ventricular pressure, severe coronary atherosclerotic heart disease; 12. Patients who refused to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
30-day all-cause mortality;

Secondary

MeasureTime frame
Cardiac function parameters included serum troponin levels, electrocardiographic findings, and echocardiographic assessments.;Renal indicators: requirement for renal replacement therapy within 30 days, serum creatinine levels and urine output, and the incidence and staging of acute kidney injury (AKI).;

Countries

China

Contacts

Public ContactXiangrong Zuo

Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)

13913979197@139.com+86 25 68303061

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026