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

NCT02885168 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-08-31

No results posted yet for this study

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.

Conditions

  • Septic Shock

Interventions

DRUG

Recombinant Activated Protein C

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

DEVICE

Near-infrared spectroscopy (NIRS)

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.

DRUG

Phenylephrine

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.

BIOLOGICAL

Blood sample

Analysis of inflammation and cellular adhesion markers and free radicals

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Principal Investigators

  • Bruno LEVY · Réanimation Médicale - Hôpital de Brabois - CHRU Nancy

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-04-30
Completion
2009-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02885168 on ClinicalTrials.gov