A study on the effect of a specific medicine (Methylene Blue) in treating patients with low blood pressure
Phase 3
- Conditions
- Health Condition 1: I00-I99- Diseases of the circulatory systemHealth Condition 2: C00-D49- Neoplasms
- Registration Number
- CTRI/2024/03/064309
- Lead Sponsor
- TMC Research Administrative Council
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Adults admitted to the ICU with refractory septic shock with hypotension (MAP below 65 mm Hg OR diastolic BP below 60 mm Hg) despite fluid resuscitation and use of vasopressors – noradrenaline more than or equal to 0.25 mcg/kg/min and vasopressin at 0.04 IU/min.
2.Consent from the LAR to participate in the study
Exclusion Criteria
1.Known allergy to methylene blue
2.Known G6PD deficiency or any hemolytic disorder
3.Pre-existing cardiovascular disease
4.Previously recorded ejection fraction lesser than 40 percent
5.Patients with survival expectancy less than 24 hours
6.Patients whose LAR refuse consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to resolution of shockTimepoint: Until death or ICU discharge
- Secondary Outcome Measures
Name Time Method 2.Response to methylene blue therapy will be defined as increase in mean arterial pressure by 10 percent and (or) or reduction in dosage requirement of other vasopressor medication. Mean arterial pressure recordings will be measured using radial or femoral arterial lines. This will be recorded at the start of infusion, at 1 hour, 12 hours, 24 hours and 96 hours after initiation of the infusion of the study drug following randomization. <br/ ><br>3.ICU and hospital mortality <br/ ><br>4.Duration of vasopressor therapy and vasopressor-free days <br/ ><br>5.Duration of invasive mechanical ventilation and ventilator-free days <br/ ><br>6.Delta SOFA score <br/ ><br>7.Need for renal replacement therapy and RRT free days <br/ ><br>8.Any possible adverse effects to methylene blue: Methylene blue has been used extensively without any adverse effects. <br/ ><br>Timepoint: Until death or ICU discharge