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

Phase 2

Completed

• Conditions: Sepsis; Septic Shock
• Interventions: Drug: Placebo comparator; Drug: Human protein C concentrate; Drug: Activated protein C

• Registration Number: NCT01411670
• Lead Sponsor: University of Roma La Sapienza

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.

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-05
• Study First Posted: 2011-08-08
• Primary Completion: 2015-02
• Study Completion: 2015-04
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Severe sepsis or septic shock with plasma activity of protein C < 60 %

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Exclusion Criteria

• Pregnancy
• Risk of Bleeding
• Hemorragia
• age < 18

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo comparator	Standard treatment
Human protein C concentrate	Human protein C concentrate	-
activated protein C	Activated protein C	Continuous infusion of Activated Protein C

Primary Outcome Measures

Name	Time	Method
plasma protein C activity	over a period of 72 hours

Secondary Outcome Measures

Name	Time	Method
sublingual microcirculatory blood flow	over a period of 72 hours	Systemic hemodynamics,sublingual microcirculatory blood flow, organ function, citokynes.

Trial Locations

Locations (1)

Departement of Anesthesiology and Intensive Care of the University of Rome La Sapienza; 🇮🇹 Rome, Italy