Administration of Human Protein C Concentrates in Patient... | NCT01411670

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

NCT01411670

Sponsor

University of Roma La Sapienza

Status

Completed

Last Update Posted

Dec 2, 2015Estimated

Enrollment

60Actual

Phase

Phase 2

Conditions

Sepsis
Septic Shock

Interventions

Human protein C concentrate
Activated protein C
Placebo comparator

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Feb 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Aug 5, 2011

First Submission Date that Met QC Criteria

Aug 5, 2011

First Posted Date

Aug 8, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2015

Last Update Posted Date

Dec 2, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrea Morelli, associate professor, University of Roma La SapienzaPrincipal Investigator

Lead Sponsor

University of Roma La SapienzaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Human protein C concentrate	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%	Human protein C concentrate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
plasma protein C activity		over a period of 72 hours

Secondary Outcomes

Measure	Description	Time Frame
sublingual microcirculatory blood flow	Systemic hemodynamics,sublingual microcirculatory blood flow, organ function, citokynes.	over a period of 72 hours

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrea Morelli, MD	University of Roma La Sapienza	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departement of Anesthesiology and Intensive Care of the University of Rome La Sapienza		Rome		00161	Italy

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis
D012772	Shock, Septic

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011486	Protein C

Ancestor Terms

ID	Term
D004792	Enzyme Precursors
D045762	Enzymes and Coenzymes
D006023	Glycoproteins
D006001	Glycoconjugates

Browse Leaves

Not provided

Browse Branches

Not provided