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

NCT ID: NCT01411670

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-04-30

Brief Summary

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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

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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

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Sepsis Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Human protein C concentrate

Group Type EXPERIMENTAL

Human protein C concentrate

Intervention Type DRUG

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%

activated protein C

Continuous infusion of Activated Protein C

Group Type ACTIVE_COMPARATOR

Activated protein C

Intervention Type DRUG

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

Placebo

Standard treatment

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type DRUG

Standard treatment

Interventions

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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%

Intervention Type DRUG

Activated protein C

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

Intervention Type DRUG

Placebo comparator

Standard treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnancy
* Risk of Bleeding
* Hemorragia
* age \< 18
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Andrea Morelli

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Morelli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Roma La Sapienza

Locations

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Departement of Anesthesiology and Intensive Care of the University of Rome La Sapienza

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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2112

Identifier Type: -

Identifier Source: org_study_id