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Effects of Acute Systemic Inflammation on Arterial Stiffness and Microcirculation. (IRIGA)

This study is currently recruiting participants.
Verified December 2012 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01556373
First received: February 23, 2012
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

This study aims to assess the effect of acute inflammation on arterial stiffness and microcirculation. Patients with severe sepsis will be compared with age- and sex-matched healthy volunteers.

The primary outcome is the carotid-femoral pulse wave velocity. The other outcome measures are: systemic hemodynamics (systolic, diastolic, mean and pulse blood pressures, heart rate, cardiac output, left ventricular ejection fraction, systemic vascular resistances), central hemodynamics (aortic systolic, diastolic, mean and pulse pressures, and augmentation index), thenar tissue oxygen saturation, biological makers of inflammation (plasma fibrinogen, C-reactive protein, interleukin-6, matrix metalloproteinases -2, -9, tissue inhibitor of metalloproteinase 1), and plasma catecholamine concentrations (epinephrine, norepinephrine).


Condition Intervention
Severe Sepsis
 Other: NA : non interventional study

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Acute Systemic Inflammation on Arterial Stiffness and Microcirculation.

Resource links provided by NLM:

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Carotid-femoral pulse wave velocity [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Systemic hemodynamics [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    • Systolic, diastolic, mean, and pulse blood pressures, and heart rate
    • Cardiac output, left ventricular ejection fraction, systemic vascular resistances

  • Central aortic hemodynamic [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    • Aortic systolic, diastolic, mean and pulse pressures,
    • Augmentation index

  • Micro-circulation [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Thenar tissue oxygen saturation

  • Biological markers from plasma samples [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    • fibrinogen
    • C-reactiv protein
    • Interleukin-6
    • matrix metalloproteinases -2, -9, and tissue inhibitor of metalloproteinase 1
    • epinephrine and norepinephrine


Biospecimen Retention:   Samples Without DNA

serum


Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
severe sepsis
patients with severe sepsis
 Other: NA : non interventional study
NA : non interventional study
Other Name: NA : non interventional study
healthy volunteers
healthy volunteers matched to patients on age and sex
 Other: NA : non interventional study
NA : non interventional study
Other Name: NA : non interventional study

Detailed Description:

In a model of acute inflammation induced by salmonella typhi vaccination in healthy volunteers, it has been shown that acute systemic inflammation increased arterial stiffness. Since increased arterial stiffness (assessed by carotid-femoral pulse wave velocity) is an independent prognosis marker of cardiovascular risk in many chronic diseases such as hypertension, renal failure or diabetes mellitus, it could also be a marker of severity in acute inflammation states. Severe sepsis is a leading cause of hospitalisation in intensive care units, and constitutes a state of acute inflammation. It remains however to confirm that arterial stiffness is increased in this clinical conditions before evaluating its prognosis value.

This study aims to assess the effect of severe sepsis on arterial stiffness and microcirculation. Patients with severe sepsis will be compared with age- and sex-matched healthy volunteers.

The primary outcome is the carotid-femoral pulse wave velocity. The other outcome measures are: systemic hemodynamics (systolic, diastolic, mean and pulse blood pressures, heart rate, cardiac output, left ventricular ejection fraction, systemic vascular resistances), central hemodynamics (aortic systolic, diastolic, mean and pulse pressures, and augmentation index), thenar tissue oxygen saturation, biological makers of inflammation (plasma fibrinogen, C-reactive protein, interleukin-6, matrix metalloproteinases -2, -9, tissue inhibitor of metalloproteinase 1), and plasma catecholamine concentrations (epinephrine, norepinephrine).

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

20 patients with severe sepsis. 20 healthy volunteers age- and sex-matched .

Criteria

Inclusion Criteria:

  • Group of healthy volunteers:

    • male or female aged 18 to 40 years, age- and sex-matched with septic patients
    • Normal clinical examination and normal 12-lead ECG
    • Routines biological tests in the normal range of the laboratories.
    • Body mass index between 18 and 27 kg/m²
    • No smoker (for at least one year)
    • Without hypertension, diabetes mellitus, dyslipidemia, or family history of premature vascular disease
    • Written informed consent

  • Patients group :

    • Male or female aged 18 to 40 years

    • Severe sepsis defined by the presence of:

      • a systemic inflammatory response syndrome
      • the evidence of an infection
      • the presence of at least one organ failure or signs of tissue hypoperfusion.
    • Body mass index between 18 and 27 Kg/m²
    • No smoker (for at least one year)
    • Without hypertension, diabetes mellitus, dyslipidemia, or family history of premature vascular disease
    • Written informed consent from the patients or their relatives

Exclusion Criteria:

  • Healthy volunteers group:

    • legal protection or persons deprived of liberty
    • bacterial or viral infection in the month preceding inclusion
    • current medication
    • pregnancy or breastfeeding
    • exclusion period stated on the national register for persons who participate to biomedical research

  • Patients group :

    • legal protection or persons deprived of liberty
    • vasopressor therapy
    • bacterial or viral infection in the month preceding inclusion
    • known cardiomyopathy
    • pregnancy or breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556373

Contacts
Contact: Bruno LAVIOLLE, MD, PhD +33-299-2896-68 bruno.laviolle@chu-rennes.fr
Contact: Eric BELLISSANT, MD, PhD +33-299-289-200 eric.bellissant@chu-rennes.fr

Locations
France
Unité d'Investigation Clinique - Hôpital de Pontchaillou Recruiting
Rennes, France, 35033
Contact: Bruno LAVIOLLE, MD, PhD         bruno.laviolle@chu-rennes.fr    
Principal Investigator: Bruno LAVIOLLE, MD, PhD            
Service de Réanimation Chirurgicale - Hôpital de Pontchaillou Recruiting
Rennes, France, 35033
Contact: Bruno LAVIOLLE, MD, PhD         bruno.lavioll@chu-rennes.fr    
Principal Investigator: Bruno LAVIOLLE, MD, PhD            
Sub-Investigator: Pascale LE MAGUET, MD            
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Bruno LAVIOLLE, MD, PhD Rennes University Hospital
Study Chair: Eric BELLISSANT, MD, PhD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01556373     History of Changes
Other Study ID Numbers: 2010-A00612-37
Study First Received: February 23, 2012
Last Updated: December 3, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
acute systemic inflammation
arterial stiffness
Carotid-femoral pulse wave velocity

Additional relevant MeSH terms:
Inflammation
Sepsis
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on May 19, 2013