drugset / Trial / NCT03038503

What Should be the Next Vasopressor for Severe Septic Shock? Methylene Blue or Terlipressin

NCT03038503

Phase 3 Unknown 60 enrolled Ramathibodi Hospital
RandomizedParallel-groupSingle-blindTreatment

Summary

The ICU mortality rate of patients with septic shock was still high upto 54.1%.In first 6 hours of resuscitation, the goals of resuscitation in sepsis shock after adequate fluid resuscitation is MAP ≥65 mmHg. In refractory septic shock patient, prolong shock correlate with poor outcome due to multiple organ failure. Alternative vasopressor in septic shock with catecholamine resistance has been studied such as terlipressin, methylene blue * Terlipressin (TP) mediate vasoconstriction via V1 receptors coupled to phospholipase C, and increases intracellular Ca2+ concentration * Methylene blue (MB) directly inhibits nitric oxide synthase (NOS) by inhibit the enzyme guanylate cyclase (GC)

Timeline

Start
2016-12
Primary completion
2018-12
Completion
2018-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylene Blue Diagnostic / imaging agent 0.5 mg/kg Intravenous
Subject Terlipressin Peptide 1 mg Intravenous