drugset / Trial / NCT02885168

Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C

NCT02885168

Phase 4 Completed 30 enrolled Central Hospital, Nancy, France
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose is to demonstrate that vasoreactivity of patients with septic shock evaluated with dose-response curve is diminished in septic shock and ameliorated by activated protein C (APC). This amelioration is correlated to decrease of inflammation, decrease of reactive oxygen species (ROS) markers and increase of circulating catecholamines.

Timeline

Start
2008-02
Primary completion
2009-04
Completion
2009-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Drotrecogin alfa (activated) Protein / enzyme biologic 24 ug/kg Intravenous
Subject Phenylephrine Small molecule 0 ug/kg
Subject Phenylephrine Small molecule 0.02 ug/kg
Subject Phenylephrine Small molecule 0.05 ug/kg
Subject Phenylephrine Small molecule 0.1 ug/kg
Subject Phenylephrine Small molecule 0.2 ug/kg
Subject Phenylephrine Small molecule 0.5 ug/kg
Subject Phenylephrine Small molecule 0.75 ug/kg
Subject Phenylephrine Small molecule 1 ug/kg
Subject Phenylephrine Small molecule 1.5 ug/kg
Subject Phenylephrine Small molecule 3 ug/kg
Subject Phenylephrine Small molecule 4.5 ug/kg
Subject Phenylephrine Small molecule 6 ug/kg
Subject Phenylephrine Small molecule 9 ug/kg
Subject Phenylephrine Small molecule 12 ug/kg