Effects of Acute Systemic Inflammation on Arterial Stiffness and Microcirculation.

NCT01556373 | Completed

• 1 other identifier: 2010-A00612-37
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to assess the effect of acute inflammation on arterial stiffness and microcirculation. Patients with severe sepsis will be compared with age-, sex- and cardiovascular risk factors-matched controls. 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).

Conditions

Severe Sepsis

Keywords

acute systemic inflammation; arterial stiffness; Carotid-femoral pulse wave velocity

Outcome Measures

Primary Outcomes (1)

• Carotid-femoral pulse wave velocity

  1 day

Secondary Outcomes (4)

• Systemic hemodynamics

  1 day

• Central aortic hemodynamic

  1 day

• Micro-circulation

  1 day

• Biological markers from plasma samples

  1 day

Study Arms (2)

severe sepsis

patients with severe sepsis

Other: NA : non interventional study

Controls

Controls matched to patients on age, sex and cardiovascular risk factors

Other: NA : non interventional study

Interventions

NA : non interventional study OTHER

NA : non interventional study

Controls; severe sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

20 patients with severe sepsis. 20 controls matched on age, sex and cardiovascular risk factors .

You may qualify if:

• Control group :
• male or female aged at least 18 years, matched on age, sex and cardiovascular risk factors (smoking, hypertension, diabetes and treated dyslipidemia) 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
• Written informed consent
• Patients group :
• Male or female aged at least 18 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
• Written informed consent from the patients or their relatives

You may not qualify if:

• Control group :
• legal protection or persons deprived of liberty
• current medication
• pregnancy or breastfeeding
• Patients group :
• legal protection or persons deprived of liberty
• vasopressor therapy
• known cardiomyopathy
• pregnancy or breastfeeding

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (2)

Service de Réanimation Chirurgicale - Hôpital de Pontchaillou

Rennes, 35033, France

Location

Unité d'Investigation Clinique - Hôpital de Pontchaillou

Rennes, 35033, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bruno LAVIOLLE, MD, PhD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

• Eric BELLISSANT, MD, PhD

  Rennes University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: March 16, 2012
• Study Start: February 23, 2012
• Primary Completion: April 16, 2015
• Study Completion: April 16, 2015
• Last Updated: December 27, 2019

Record last verified: 2019-12

Locations

FR (2)