Septic Shock
Conditions
Keywords
septic shock, methylene blue, mortality
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.
Interventions
DRUGMethylene Blue
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.
DRUGPlacebo
An identical volume of 5% dextrose solution from the placebo drug bag will be administered to patients using the same protocol as intervention arm.
Sponsors
Northern Jiangsu People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to shock reversal | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 28-day mortality | 28 days after randomization | All-cause mortality at day 28 after randomization |
| 90-day mortality | 90 days after randomization | All-cause mortality at day 90 after randomization |
| ICU mortality | 90 days after randomization | All-cause mortality at ICU discharge |
| Hospital mortality | 90 days after randomization | All-cause mortality at hospital discharge |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORQingquan Lyu, Master
Northern Jiangsu People's Hospital
Outcome results
None listed