Severe SepsisIRIGANCT01556373
Effects of Acute Systemic Inflammation on Arterial Stiffness and Microcirculation.
An observational study of Severe Sepsis, run by Rennes University Hospital at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Severe Sepsis
- What is being tested?
- NA : non interventional study
- How many people
- 8 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Feb 2012to 16 Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 20 patients with severe sepsis. 20 controls matched on age, sex and cardiovascular risk factors .
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de Réanimation Chirurgicale - Hôpital de Pontchaillou
Rennes, 35033
Unité d'Investigation Clinique - Hôpital de Pontchaillou
Rennes, 35033
About this study
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).
Read the 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-, 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
- Being tested
- NA : non interventional study
- Keywords
- acute systemic inflammation, arterial stiffness, Carotid-femoral pulse wave velocity
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NA : non interventional studyOther
NA : non interventional study
| Study group | Role | What they receive |
|---|---|---|
| severe sepsis | patients with severe sepsis Receives: Other: NA : non interventional study | |
| Controls | Controls matched to patients on age, sex and cardiovascular risk factors Receives: Other: NA : non interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid-femoral pulse wave velocity
Measured: 1 day
Secondary outcomes (4)
Systemic hemodynamics
- Systolic, diastolic, mean, and pulse blood pressures, and heart rate
- Cardiac output, left ventricular ejection fraction, systemic vascular resistances
Measured: 1 day
Central aortic hemodynamic
- Aortic systolic, diastolic, mean and pulse pressures,
- Augmentation index
Measured: 1 day
Micro-circulation
Thenar tissue oxygen saturation
Measured: 1 day
Biological markers from plasma samples
- fibrinogen
- C-reactiv protein
- Interleukin-6
- matrix metalloproteinases -2, -9, and tissue inhibitor of metalloproteinase 1
- epinephrine and norepinephrine
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study start23 Feb 2012
- Primary completion16 Apr 2015
- Study completion16 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno LAVIOLLE, MD, PhD, Principal investigator, Rennes University HospitalEric BELLISSANT, MD, PhD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556373
- Sponsor's protocol ID
- 2010-A00612-37
- Acronym
- IRIGA
- Status last verified
- Dec 2019
- First submitted
- 23 Feb 2012
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Systemic Inflammation on Arterial Stiffness and Microcirculation.
- ClinicalTrials.gov ID
- NCT01556373
- Acronym / sponsor ID
- IRIGA / 2010-A00612-37
- Conditions
- Severe Sepsis
- Keywords
- acute systemic inflammation, arterial stiffness, Carotid-femoral pulse wave velocity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 23 Feb 2012 (actual)
- Primary completion
- 16 Apr 2015 (actual)
- Study completion
- 16 Apr 2015 (actual)
- First posted
- 16 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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-, 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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| severe sepsis | – | Other: NA : non interventional studypatients with severe sepsis |
| Controls | – | Other: NA : non interventional studyControls matched to patients on age, sex and cardiovascular risk factors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 20 patients with severe sepsis. 20 controls matched on age, sex and cardiovascular risk factors .
Key inclusion criteria (14 listed)
- Control group :
- Patients group :
Key exclusion criteria (12 listed)
- Control group :
- Patients group :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NA : non interventional studyNA : non interventional study | Other | Controls, severe sepsis |
Primary outcome
Carotid-femoral pulse wave velocity
Time frame: 1 day
4 secondary outcomes
Systemic hemodynamics
Time frame: 1 day
Central aortic hemodynamic
Time frame: 1 day
Micro-circulation
Time frame: 1 day
Biological markers from plasma samples
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno LAVIOLLE, MD, PhD principal investigator
Rennes University Hospital
Eric BELLISSANT, MD, PhD study chair
Rennes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis, run by Rennes University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotid-femoral pulse wave velocity (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2019.