NCT01411670

Administration of Human Protein C Concentrates in Patients With Sepsis and Septic Shock.

Administration of Human Protein C Concentrates in Patients With Sepsis and Septic Shock: Effects on Microcirculation and Organ Function.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effects on systemic hemodynamics, microcirculation and organ function of human Protein C concentrate in patients with sepsis and septic shock.

Detailed description

Sixty septic patients with plasma protein C activity \< 60 % will be enrolled in the study. Patients will be randomly allocated to be treated with either a) a continuous infusion of human Protein C concentrate at 3 UI/Kg/hr for 72 hours to reach plasma protein C activity between 70 and 120 % b)to a continuous infusion of activated protein C at 24 micrograms/Kg/hr for 96 hours, c) a standard teatment(control; each n = 20). In all groups, norepinephrine will be titrated to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg. Data from right heart catheterization, from microcirculation (SDF imaging) and from organ function as well as norepinephrine requirements will be obtained at baseline and after 24, 48, 72 hours.

Conditions

• Sepsis
• Septic Shock

Interventions

Type	Name	Description
DRUG	Human protein C concentrate	Continuous infusion of human protein C concentrate at the dose of 3 UI/Kg/Hr to reach a protein C plasma activity of 70-120%
DRUG	Activated protein C	Continuous infusion of activated protein C at the dose of 24 micrograms/Kg/Hr for 96 hours
DRUG	Placebo comparator	Standard treatment

Timeline

• Start date: 2011-01-01
• Primary completion: 2015-02-01
• Completion: 2015-04-01
• First posted: 2011-08-08
• Last updated: 2015-12-02

Locations

1 site across 1 country: Italy