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

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ClinicalTrials.gov Identifier: NCT01411670
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):

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  (Clinical Trial)
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 : January 2011
Primary Completion Date : February 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources

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


Outcome Measures

Primary Outcome Measures :
  1. plasma protein C activity [ Time Frame: over a period of 72 hours ]

Secondary Outcome Measures :
  1. sublingual microcirculatory blood flow [ Time Frame: over a period of 72 hours ]
    Systemic hemodynamics,sublingual microcirculatory blood flow, organ function, citokynes.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Risk of Bleeding
  • Hemorragia
  • age < 18
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411670


Locations
Italy
Departement of Anesthesiology and Intensive Care of the University of Rome La Sapienza
Rome, Italy, 00161
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Principal Investigator: Andrea Morelli, MD University of Roma La Sapienza
More Information

Responsible Party: Andrea Morelli, associate professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01411670     History of Changes
Other Study ID Numbers: 2112
First Posted: August 8, 2011    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: December 2015

Keywords provided by Andrea Morelli, University of Roma La Sapienza:
Human Protein C
Activated protein C
Microcirculation
Septic Shock
Sepsis

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Protein C
Drotrecogin alfa activated
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents