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

Sepsis Clinical Trial

Official title:

Administration of Human Protein C Concentrates in Patients With Sepsis and Septic Shock: Effects on Microcirculation and Organ Function.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411670
• Other study ID #: 2112
• Status: Completed
• Phase: Phase 2
• First received: August 5, 2011
• Last updated: December 1, 2015
• Start date: January 2011
• Est. completion date: April 2015

Study information

• Verified date: December 2015
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy

• Risk of Bleeding

• Hemorragia

• age < 18

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Shock
• Shock, Septic
• Toxemia

Intervention

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%
• Activated protein C
Continuous infusion of activated protein C at the dose of 24 micrograms/Kg/Hr for 96 hours
• Placebo comparator
Standard treatment

Locations

Country	Name	City	State
Italy	Departement of Anesthesiology and Intensive Care of the University of Rome La Sapienza	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma protein C activity		over a period of 72 hours	No
Secondary	sublingual microcirculatory blood flow	Systemic hemodynamics,sublingual microcirculatory blood flow, organ function, citokynes.	over a period of 72 hours	No