Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C (PCA)

Central Hospital, Nancy, France

Status and phase: Completed; Phase 4

Conditions: Septic Shock

Treatments: Drug: Phenylephrine; Device: Near-infrared spectroscopy (NIRS); Drug: Recombinant Activated Protein C; Biological: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT02885168

2007-002319-16

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Shock + Treatment

Experimental group

Description:

Patients treated with activated protein C

Treatment:

Biological: Blood sample

Device: Near-infrared spectroscopy (NIRS)

Drug: Phenylephrine

Drug: Recombinant Activated Protein C

Shock

Other group

Description:

Patients not treated with activated protein C

Treatment:

Biological: Blood sample

Device: Near-infrared spectroscopy (NIRS)

Drug: Phenylephrine