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Completed

NCT Number: NCT01411670

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

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Rome, 00161, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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%

Activated protein C

Drug

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

placebo comparator

Drug

Standard treatment

Primary outcomes

  1. plasma protein C activity

    Time frame: over a period of 72 hours

Secondary outcomes

  1. sublingual microcirculatory blood flow

    Time frame: over a period of 72 hours

    Systemic hemodynamics,sublingual microcirculatory blood flow, organ function, citokynes.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 8, 2011
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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