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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01411670

Enrollment

Registered

2011-08-08

Start date

2011-01-31

Completion date

2015-04-30

Last updated

2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, Septic Shock

Keywords

Human Protein C, Activated protein C, Microcirculation, Septic Shock, Sepsis

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.

Interventions

DRUGHuman 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%

DRUGActivated protein C

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

DRUGPlacebo comparator

Standard treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Pregnancy * Risk of Bleeding * Hemorragia * age \< 18

Design outcomes

Primary

Measure	Time frame
plasma protein C activity	over a period of 72 hours

Secondary

Measure	Time frame	Description
sublingual microcirculatory blood flow	over a period of 72 hours	Systemic hemodynamics,sublingual microcirculatory blood flow, organ function, citokynes.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026