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

University of Roma La Sapienza

Status and phase: Completed; Phase 2

Conditions: Septic Shock; Sepsis

Treatments: Drug: Human protein C concentrate; Drug: Activated protein C; Drug: Placebo comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT01411670

2112

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

Human protein C concentrate

Experimental group

Treatment:

Drug: Human protein C concentrate

activated protein C

Active Comparator group

Description:

Continuous infusion of Activated Protein C

Treatment:

Drug: Activated protein C

Placebo

Placebo Comparator group

Description:

Standard treatment

Treatment:

Drug: Placebo comparator