NCT03038503

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ramathibodi Hospital · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Septic Shock
• Refractory Shock

Interventions

Type	Name	Description
DRUG	Methylene Blue	after defined refractory shock (need NE\>0.5 mcg/kg/min) add Methylene blue 1 mg/kg iv drip then 2 hr later drip 0.5 mg/kg/hr\*4 hr (intervention add on to standard care)
DRUG	Terlipressin	after defined refractory shock (need NE\>0.5 mcg/kg/min) add terlipressin 1 mg IV then repeated dose 20 min later if unstable BP (intervention add on to standard care)

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2017-01-31
• Last updated: 2018-08-29

Locations

1 site across 1 country: Thailand