Two different medicines named Methylene blue and vasopressin will be compared as second line blood pressure raising medication in patients having infection with low blood pressure

Phase 3

Conditions: Health Condition 1: I958- Other hypotension

Registration Number: CTRI/2024/08/072434

Lead Sponsor: All India Institute Of Medical Sciences New Delhi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Adult patients with septic shock requiring norepinephrine support of =0.2 µg/kg/min for a minimum of 30 minutes despite fluid resuscitation with a minimum of 20 ml/kg to maintain mean arterial pressure (MAP) =65 mm Hg

Exclusion Criteria

1.Patients with allergy to methylene blue

2.Patients with known Glucose-6-phosphate dehydrogenase (G6PD) deficiency

3.Patients with familial history of G6PD deficiency

4.Patients with known haemolytic anaemia

5.Patients with severe acute respiratory distress syndrome (ARDS)

6.Pregnant and lactating women

7.Patients with concurrent haemorrhagic or obstructive shock

8.Patients with acute kidney injury KDIGO grade 3, pre-existing chronic renal disease

9.Patients with pre-existing chronic liver disease

10.Patients with coronary artery disease

11.Patients on MAO inhibitors and selective serotonin re-uptake inhibitors

12.Patients who have already been administered either of the two study drugs at any point during the disease

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference in the average sequential organ failure assessment (SOFA) score at day 7Timepoint: The difference in the average sequential organ failure assessment (SOFA) score at day 7

Secondary Outcome Measures

Name	Time	Method
1. Duration of requirement of vasopressors <br/ ><br>2. Vasopressor- free days (number of days alive and free of vasopressors at day 30) <br/ ><br>3.Ventilator-free days (number of days alive and free of mechanical ventilator at day 30) <br/ ><br>4. Renal replacement therapy free days (number of days alive and free of renal replacement therapy at day 30) <br/ ><br>5. Lactate levels <br/ ><br>6. Incidence of acute kidney injury (AKI) <br/ ><br>7. ICU- free days ( number of days alive and out of the ICU at day 30) <br/ ><br>8. ICU mortality, hospital mortality or any cause mortality at day 30.Timepoint: Day 30