Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C
PCA
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2008
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 26, 2016
CompletedFirst Posted
Study publicly available on registry
August 31, 2016
CompletedAugust 31, 2016
August 1, 2016
1.2 years
August 26, 2016
August 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Vascular reactivity measured with dose-response to phenylephrine
baseline
Vascular reactivity measured with dose-response to phenylephrine
4 hours
Vascular reactivity measured with dose-response to phenylephrine
24 hours
Study Arms (2)
Shock + Treatment
EXPERIMENTALPatients treated with activated protein C
Shock
OTHERPatients not treated with activated protein C
Interventions
24 μg/kg/h during 96 hours - intravenous injection
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.
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.
Analysis of inflammation and cellular adhesion markers and free radicals
Eligibility Criteria
You may qualify if:
- \- Patients with septic shock as determined by standard criteria (including infection and severe infection)
You may not qualify if:
- Pregnant women
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bruno LEVY
Réanimation Médicale - Hôpital de Brabois - CHRU Nancy
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2016
First Posted
August 31, 2016
Study Start
February 1, 2008
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
August 31, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share