Health Condition 1: B998- Other infectious disease
Conditions
Interventions
Intervention1: Methylene Blue: Intravenous methylene blue 1 mg/kg loading dose over 20 minutes followed by continuous infusion at 0.5 to 1 mg/kg/hour as adjunct vasopressor therapy after norepinephrin
Sponsors
Amrita Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 18 years or above with chronic liver disease or acute on chronic liver failure and septic shock as defined by Sepsis-3 criteria will be included. Septic shock will be defined as suspected or confirmed infection with requirement of norepinephrine to maintain mean arterial pressure of at least 65 mmHg despite adequate fluid resuscitation and serum lactate more than 2 mmol/L. Patients will be eligible when norepinephrine dose reaches 0.25 mcg/kg/min or more and a second vasopressor is required. Written informed consent will be obtained from the patient or legally authorized representative.
Exclusion criteria
Exclusion criteria: More than 24 hours since initiation of norepinephrine infusion Pregnancy or lactation Presence of hemorrhagic, obstructive, or hypovolemic shock Patients planned for emergency damage-control surgery Major burn injury Known personal or family history of glucose-6-phosphate dehydrogenase (G6PD) deficiency Known allergy or hypersensitivity to methylene blue, phenothiazines, or related dyes Use of selective serotonin reuptake inhibitors (SSRIs) within the previous 4 weeks Refusal of consent by patient or legally authorized representative
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to vasopressor discontinuation defined as the duration in hours from initiation of study drug infusion to cessation of all vasopressors for at least 24 consecutive hoursTimepoint: During ICU stay following randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Vasopressor free days All cause mortality Duration of mechanical ventilation Length of ICU stay Length of hospital stay Serum lactate level Norepinephrine dose requirement Serum creatinine Serum bilirubin Aspartate aminotransferase AST Alanine aminotransferase ALT Incidence of arrhythmias Incidence of ischemic complications Incidence of serotonin syndrome Incidence of methemoglobinemiaTimepoint: 28 days after randomization 28 days after randomization During ICU stay until ICU discharge At ICU discharge At hospital discharge Baseline 24 hours & 48 hours after intervention Baseline immediately after intervention 24 hours & 48 hours Baseline 24 hours & 48 hours Baseline 24 hours & 48 hours Baseline 24 hours & 48 hours Baseline 24 hours & 48 hours During ICU stay & up to 28 days During ICU stay & up to 28 days During ICU stay & up to 28 days During ICU stay & up to 28 days | — |
Countries
India
Contacts
Public ContactDr Varun B Nair
Amrita Institute of Medical Sciences
Outcome results
None listed