Comparison of two different medicines named Methylene Blue and Vasopressin for increasing blood pressure in patients with infection and low blood pressure
Phase 3
- Conditions
- Health Condition 1: I958- Other hypotension
- Registration Number
- CTRI/2023/06/053979
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Septic Shock defined as suspected or proven infection and increase in qSOFA score of 2 or more from baseline, with lactate levels of >2mmol/L and requiring vasopressor agents to maintain a MAP more than 65mmHg despite adequate fluid resuscitation(guided by FALLS protocol) and
2. MAP < 65mmHg despite noradrenaline infusion
0.5 microgram per Kg per min.
Exclusion Criteria
1.Age < 18 years
2.Pregnant female
3.Undergoing palliative treatment or end-of-life care.
4.Post Cardiopulmonary Resuscitation(CPR)
5.Anuric( <50ml/day)
6.Allergic to methylene blue
7.Patients of MAOI and SSRI
8.Known G6PD deficiency
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients attaining a Mean Arterial Pressure of at least 65mmHg at 6 hours after starting Methylene Blue compared to VasopressinTimepoint: 6 hours
- Secondary Outcome Measures
Name Time Method 1.To Compare Responders between Methylene Blue and Vasopressin in terms of achieving a 10% reduction in the doses of Norepinephrine needed to maintain a MAP of 65mmHg in Septic shock adult patients. <br/ ><br>2. Hemodynamic parameters (Heart rate, SBP, DBP, MAP till 6 hours) <br/ ><br>3. Cumulative/ time-weighted average requirement of vasopressors (Noradrenaline, Vasopressin and Methylene Blue) <br/ ><br>4. Lactate clearance at 6 hours. <br/ ><br>5. Urine output (to be monitored during MB/ Vasopressin infusion on hourly basis till 6 hours. <br/ ><br>6. To assess mortality rates at 24 hours and in-hospital mortality. <br/ ><br>7. Safety of Methylene Blue in terms of hall in Hb from baseline, Methhemoglobinemia, worsening P/F ratio (till 6 hours). <br/ ><br>Timepoint: 6 hours, 24 hours and at hospital discharge / death