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The purpose of this study is to evaluate the efficacy and safety of methylene blue among adult patients with septic shock.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Placebo | Placebo Comparator | 5% dextrose solution in a volume to match experimental arm component. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylene Blue | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day mortality | All-cause mortality at day 28 after randomization | 28 days after randomization |
| 90-day mortality | All-cause mortality at day 90 after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| ICU length of stay | Time in days until ICU discharge | 90 days after randomization |
| hospital length of stay | Time in days until hospital discharge |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qingquan Lyu, Master | Northern Jiangsu People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern Jiangsu people's hospital | Yangzhou | Jiangsu | 225000 | China |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D008751 | Methylene Blue |
| ID | Term |
|---|---|
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
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|
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| Placebo | Drug | An identical volume of 5% dextrose solution from the placebo drug bag will be administered to patients using the same protocol as intervention arm. |
|
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| 90 days after randomization |
| ICU mortality | All-cause mortality at ICU discharge | 90 days after randomization |
| Hospital mortality | All-cause mortality at hospital discharge | 90 days after randomization |
| 90 days after randomization |
| ICU-free days up to day 28 | Total number of days alive and free of ICU stay during the 28 days after randomization. | 28 days after randomization |
| vasopressor-free days up to day 28 | Total number of days alive and free of vasopressor during the 28 days after randomization. | 28 days after randomization |
| ventilator support-free days up to day 28 | Total number of days alive and free of ventilator support during the 28 days after randomization. | 28 days after randomization |
| CRRT-free days up to day 28 | Total number of days alive and free of CRRT during the 28 days after randomization. | 28 days after randomization |
| 72h lactate | lactate level at 72h after randomization | 72 hours after randomization |
| 72h Delta SOFA | Initial SOFA score at enrollment-SOFA score after 72 h;If the patient discharged within 72 h after being enrolled in the study, the SOFA score at discharge was used for the analysis. | 72 hours after randomization |
| 72h P/F | P/F at 72h after randomization | 72 hours after randomization |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |