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

Primary Purpose

Sepsis, Septic Shock

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Human protein C concentrate
Activated protein C
Placebo comparator
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring Human Protein C, Activated protein C, Microcirculation, Septic Shock, Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Human protein C concentrate

activated protein C

Placebo

Arm Description

Continuous infusion of Activated Protein C

Standard treatment

Outcomes

Primary Outcome Measures

plasma protein C activity

Secondary Outcome Measures

sublingual microcirculatory blood flow
Systemic hemodynamics,sublingual microcirculatory blood flow, organ function, citokynes.

Full Information

First Posted
August 5, 2011
Last Updated
December 1, 2015
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT01411670
Brief Title
Administration of Human Protein C Concentrates in Patients With Sepsis and Septic Shock.
Official Title
Administration of Human Protein C Concentrates in Patients With Sepsis and Septic Shock: Effects on Microcirculation and Organ Function.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Septic Shock
Keywords
Human Protein C, Activated protein C, Microcirculation, Septic Shock, Sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Human protein C concentrate
Arm Type
Experimental
Arm Title
activated protein C
Arm Type
Active Comparator
Arm Description
Continuous infusion of Activated Protein C
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Standard treatment
Intervention Type
Drug
Intervention Name(s)
Human protein C concentrate
Intervention Description
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
Intervention Name(s)
Activated protein C
Intervention Description
Continuous infusion of activated protein C at the dose of 24 micrograms/Kg/Hr for 96 hours
Intervention Type
Drug
Intervention Name(s)
Placebo comparator
Intervention Description
Standard treatment
Primary Outcome Measure Information:
Title
plasma protein C activity
Time Frame
over a period of 72 hours
Secondary Outcome Measure Information:
Title
sublingual microcirculatory blood flow
Description
Systemic hemodynamics,sublingual microcirculatory blood flow, organ function, citokynes.
Time Frame
over a period of 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Severe sepsis or septic shock with plasma activity of protein C < 60 % Exclusion Criteria: Pregnancy Risk of Bleeding Hemorragia age < 18
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Morelli, MD
Organizational Affiliation
University of Roma La Sapienza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departement of Anesthesiology and Intensive Care of the University of Rome La Sapienza
City
Rome
ZIP/Postal Code
00161
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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