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

Methylene blue Versus Vasopressin as Second Line Vasopressor in Septic Shock- A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/072434

Enrollment

Registered

2024-08-13

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I958- Other hypotension

Interventions

Intervention1: GROUP M: Methylene blue 1 mg/kg intravenous bolus followed by 0.25 mg/kg/hour Intravenous infusion. The infusion will be continued for 96 hours or till the requirement of norepinephrine

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

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

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactKathiravan T

AIIMS, NEW DELHI

ravindrapandey1972@gmail.com9773500767

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026