Clinical trial NCT06532240: Methylene Blue for the Treatment of Septic Shock
Official title: Initiation of Methylene Blue for Septic Shock in Adults: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Septic Shock
Keywords: septic shock
methylene blue
mortality
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to shock reversal
timeFrame: 90 days after randomization
Secondary outcomes:
measure: 28-day mortality
timeFrame: 28 days after randomization
measure: 90-day mortality
timeFrame: 90 days after randomization
measure: ICU mortality
timeFrame: 90 days after randomization
measure: Hospital mortality
timeFrame: 90 days after randomization
Other outcomes:
measure: ICU length of stay
timeFrame: 90 days after randomization
measure: hospital length of stay
timeFrame: 90 days after randomization
measure: ICU-free days up to day 28
timeFrame: 28 days after randomization
measure: vasopressor-free days up to day 28
timeFrame: 28 days after randomization
measure: ventilator support-free days up to day 28
timeFrame: 28 days after randomization
measure: CRRT-free days up to day 28
timeFrame: 28 days after randomization
measure: 72h lactate
timeFrame: 72 hours after randomization
measure: 72h Delta SOFA
timeFrame: 72 hours after randomization
measure: 72h P/F
timeFrame: 72 hours after randomization
Locations:
city: Yangzhou
country: China
facility: Northern Jiangsu people's hospital
state: Jiangsu
Study officials:
affiliation: Northern Jiangsu People's Hospital
name: Qingquan Lyu, Master
role: PRINCIPAL_INVESTIGATOR
References: