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

Central Hospital, Nancy, France30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Septic Shock

Interventions

Recombinant Activated Protein CDRUG

24 μg/kg/h during 96 hours - intravenous injection

Near-infrared spectroscopy (NIRS)DEVICE

After baseline measurement, cuff is blown up to obtain a muscular saturation at 40% and then deflated. Reactive hyperthermia is measured. It is considered as an index for endothelial function.

PhenylephrineDRUG

Continuous administration of phenylephrine with electric syringe with increasing dosing levels: 0.0; 0.02; 0.05; 0.1; 0.2; 0.5; 0.75; 1.00; 1.50; 3.00; 4.50; 6.00; 9.00 et 12 µg/kg/min. Each level is maintained for 5 minutes. Administration of phenylephrine is stopped progressively with the same schema. Arterial tension through an invasive approach is measured during the test.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Vascular reactivity measured with dose-response to phenylephrine

Time frame: baseline

Vascular reactivity measured with dose-response to phenylephrine

Time frame: 4 hours

Vascular reactivity measured with dose-response to phenylephrine

Time frame: 24 hours

Data from ClinicalTrials.gov

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