Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C

Phase 4

Completed

• Conditions: Septic Shock
• Interventions: Drug: Recombinant Activated Protein C; Device: Near-infrared spectroscopy (NIRS); Drug: Phenylephrine; Biological: Blood sample

• Registration Number: NCT02885168
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2016-08
• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2016-08-26
• Last Update Submitted: 2016-08-26
• Study First Posted: 2016-08-31
• Last Update Posted: 2016-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shock + Treatment	Near-infrared spectroscopy (NIRS)	Patients treated with activated protein C
Shock + Treatment	Recombinant Activated Protein C	Patients treated with activated protein C
Shock + Treatment	Phenylephrine	Patients treated with activated protein C
Shock + Treatment	Blood sample	Patients treated with activated protein C
Shock	Near-infrared spectroscopy (NIRS)	Patients not treated with activated protein C
Shock	Blood sample	Patients not treated with activated protein C
Shock	Phenylephrine	Patients not treated with activated protein C

Primary Outcome Measures

Name	Time	Method
Vascular reactivity measured with dose-response to phenylephrine	24 hours