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

Information source: University of Roma La Sapienza
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sepsis; Septic Shock

Intervention: Human protein C concentrate (Drug); Activated protein C (Drug); Placebo comparator (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Roma La Sapienza

Official(s) and/or principal investigator(s):
Andrea Morelli, MD, Principal Investigator, Affiliation: University of Roma La Sapienza

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.

Clinical Details

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

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

Primary outcome: plasma protein C activity

Secondary outcome: sublingual microcirculatory blood flow

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

- Pregnancy

- Risk of Bleeding

- Hemorragia

- age < 18

Locations and Contacts

Departement of Anesthesiology and Intensive Care of the University of Rome La Sapienza, Rome 00161, Italy; Recruiting
Andrea Morelli, MD, Phone: +390649978024, Email: andrea.morelli@uniroma1.it
Additional Information

Starting date: January 2011
Last updated: July 8, 2014

Page last updated: August 20, 2015

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