NCT01411670

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 sepsis

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_2 sepsis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

December 1, 2015

Enrollment Period

4.1 years

First QC Date

August 5, 2011

Last Update Submit

December 1, 2015

Conditions

SepsisSeptic Shock

Keywords

Human Protein CActivated protein CMicrocirculationSeptic ShockSepsis

Outcome Measures

Primary Outcomes (1)

  • plasma protein C activity

    over a period of 72 hours

Secondary Outcomes (1)

  • sublingual microcirculatory blood flow

    over a period of 72 hours

Study Arms (3)

Human protein C concentrate

EXPERIMENTAL
Drug: Human protein C concentrate

activated protein C

ACTIVE COMPARATOR

Continuous infusion of Activated Protein C

Drug: Activated protein C

Placebo

PLACEBO COMPARATOR

Standard treatment

Drug: Placebo comparator

Interventions

Human protein C concentrateDRUG

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%

Human protein C concentrate
Activated protein CDRUG

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

activated protein C
Placebo comparatorDRUG

Standard treatment

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Rome, 00161, Italy

Location

MeSH Terms

Conditions

SepsisShock, Septic

Interventions

Protein C

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Enzyme PrecursorsEnzymes and CoenzymesGlycoproteinsGlycoconjugatesCarbohydratesBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBlood Coagulation Factor InhibitorsBiological Factors

Study Officials

  • Andrea Morelli, MD

    University of Roma La Sapienza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

August 5, 2011

First Posted

August 8, 2011

Study Start

January 1, 2011

Primary Completion

February 1, 2015

Study Completion

April 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-12

Locations

IT(1)