Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C
NCT ID: NCT02885168
Last Updated: 2016-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2008-02-29
2009-04-30
Brief Summary
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This amelioration is correlated to decrease of inflammation, decrease of reactive oxygen species (ROS) markers and increase of circulating catecholamines.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Shock + Treatment
Patients treated with activated protein C
Recombinant Activated Protein C
24 μg/kg/h during 96 hours - intravenous injection
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.
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.
Blood sample
Analysis of inflammation and cellular adhesion markers and free radicals
Shock
Patients not treated with activated protein C
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.
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.
Blood sample
Analysis of inflammation and cellular adhesion markers and free radicals
Interventions
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Recombinant Activated Protein C
24 μg/kg/h during 96 hours - intravenous injection
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.
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.
Blood sample
Analysis of inflammation and cellular adhesion markers and free radicals
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Principal Investigators
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Bruno LEVY
Role: PRINCIPAL_INVESTIGATOR
Réanimation Médicale - Hôpital de Brabois - CHRU Nancy
Other Identifiers
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2007-002319-16
Identifier Type: -
Identifier Source: org_study_id