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

Sponsor

University of Roma La Sapienza (Other)

Overall Status

Completed

CT.gov ID

NCT01411670

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis Septic Shock	Drug: Human protein C concentrate Drug: Activated protein C Drug: Placebo comparator	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Human protein C concentrate	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%
Active Comparator: activated protein C Continuous infusion of Activated Protein C	Drug: Activated protein C Continuous infusion of activated protein C at the dose of 24 micrograms/Kg/Hr for 96 hours
Placebo Comparator: Placebo Standard treatment	Drug: Placebo comparator Standard treatment

Arm

Intervention/Treatment

Experimental: Human protein C concentrate

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%

Active Comparator: activated protein C

Continuous infusion of Activated Protein C

Drug: Activated protein C

Continuous infusion of activated protein C at the dose of 24 micrograms/Kg/Hr for 96 hours

Placebo Comparator: Placebo

Standard treatment

Drug: Placebo comparator

Standard treatment

Outcome Measures

Primary Outcome Measures

plasma protein C activity [over a period of 72 hours]

Secondary Outcome Measures

sublingual microcirculatory blood flow [over a period of 72 hours]
Systemic hemodynamics,sublingual microcirculatory blood flow, organ function, citokynes.