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Completed

NCT Number: NCT01556373

Effects of Acute Systemic Inflammation on Arterial Stiffness and Microcirculation.

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Réanimation Chirurgicale - Hôpital de Pontchaillou, Rennes, France

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About this study

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-, 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Control 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

Treatment and study plan

NA : non interventional study

Other

NA : non interventional study

Primary outcomes

  1. Carotid-femoral pulse wave velocity

    Time frame: 1 day

Secondary outcomes

  1. Systemic hemodynamics

    Time frame: 1 day

    • Systolic, diastolic, mean, and pulse blood pressures, and heart rate
    • Cardiac output, left ventricular ejection fraction, systemic vascular resistances
  2. Central aortic hemodynamic

    Time frame: 1 day

    • Aortic systolic, diastolic, mean and pulse pressures,
    • Augmentation index
  3. Micro-circulation

    Time frame: 1 day

    Thenar tissue oxygen saturation

  4. Biological markers from plasma samples

    Time frame: 1 day

    • fibrinogen
    • C-reactiv protein
    • Interleukin-6
    • matrix metalloproteinases -2, -9, and tissue inhibitor of metalloproteinase 1
    • epinephrine and norepinephrine

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: IRIGA

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 16, 2012
Registry last updated
Dec 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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