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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Andrea Morelli, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01411670
First received: August 5, 2011
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Sepsis
Septic Shock
Drug: Human protein C concentrate
Drug: Activated protein C
Drug: Placebo comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • plasma protein C activity [ Time Frame: over a period of 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sublingual microcirculatory blood flow [ Time Frame: over a period of 72 hours ] [ Designated as safety issue: No ]
    Systemic hemodynamics,sublingual microcirculatory blood flow, organ function, citokynes.


Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01411670

Locations
Italy
Departement of Anesthesiology and Intensive Care of the University of Rome La Sapienza Recruiting
Rome, Italy, 00161
Contact: Andrea Morelli, MD    +390649978024    andrea.morelli@uniroma1.it   
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Principal Investigator: Andrea Morelli, MD University of Roma La Sapienza
  More Information

No publications provided

Responsible Party: Andrea Morelli, associate professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01411670     History of Changes
Other Study ID Numbers: 2112
Study First Received: August 5, 2011
Last Updated: July 8, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by 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
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 26, 2014