Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C
Overview
- Phase
- Phase 4
- Intervention
- Recombinant Activated Protein C
- Conditions
- Septic Shock
- Sponsor
- Central Hospital, Nancy, France
- Enrollment
- 30
- Primary Endpoint
- Vascular reactivity measured with dose-response to phenylephrine
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose is to demonstrate that vasoreactivity of patients with septic shock evaluated with dose-response curve is diminished in septic shock and ameliorated by activated protein C (APC).
This amelioration is correlated to decrease of inflammation, decrease of reactive oxygen species (ROS) markers and increase of circulating catecholamines.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with septic shock as determined by standard criteria (including infection and severe infection)
Exclusion Criteria
- •Pregnant women
- •Absence of signed informed consent. Due to gravity of medical situation of patients, inclusion will be possible after informed consent of a family member. As soon as possible, an informed consent will be obtained by patient
- •Contraindication to Xigris: evolutive internal bleeding , intracranial pathology, neoplasia or brain involvement, concomitant heparin therapy \>= 15 IU/kg/h, known hemorrhagic diathesis except acute coagulopathy subsequent to sepsis, severe chronic liver disease, platelet count \< 30000 x 10\^6/L, high bleeding risk, known hypersensibility to drotrecogin alfa (activated), one of excipients or bovine thrombin
Arms & Interventions
Shock + Treatment
Patients treated with activated protein C
Intervention: Recombinant Activated Protein C
Shock + Treatment
Patients treated with activated protein C
Intervention: Near-infrared spectroscopy (NIRS)
Shock + Treatment
Patients treated with activated protein C
Intervention: Phenylephrine
Shock + Treatment
Patients treated with activated protein C
Intervention: Blood sample
Shock
Patients not treated with activated protein C
Intervention: Near-infrared spectroscopy (NIRS)
Shock
Patients not treated with activated protein C
Intervention: Phenylephrine
Shock
Patients not treated with activated protein C
Intervention: Blood sample
Outcomes
Primary Outcomes
Vascular reactivity measured with dose-response to phenylephrine
Time Frame: 24 hours