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

Septic Shock Clinical Trial

— PCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02885168
• Other study ID #: 2007-002319-16
• Status: Completed
• Phase: Phase 4
• First received: August 26, 2016
• Last updated: August 26, 2016
• Start date: February 2008
• Est. completion date: April 2009

Study information

• Verified date: August 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular reactivity measured with dose-response to phenylephrine		baseline	No
Primary	Vascular reactivity measured with dose-response to phenylephrine		4 hours	No
Primary	Vascular reactivity measured with dose-response to phenylephrine		24 hours	No