ShockSeneshockNCT03559569
Impact of Endothelial and Leukocyte Senescence in Circulatory Shock States
An observational study of Shock and Cardiovascular Diseases, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Circulatory shocks (CS) are life-threatening, acute organ dysfunction. Advances in critical care medicine have decreased early hospital mortality, increasing the number of surviving patients. Regrettably, these survivors are at increased risk of new infections but also of cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shock, Cardiovascular Diseases, Infection
- What is being tested?
- Biological samples will be done to evaluate the endothelial and leukocyte senescence.
- How many people
- 520 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2019to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients admitted in the intensive care unit of the "Nouvel Hôpital Civil de Strasbourg" for a circulatory shock will be included. Healthy volunteer will be included in our Clinical Investigation Center of the "Hôpitaux Universitaires de Strasbourg"
Who may be able to join
- Circulatory shock
- patient with health care insurance
Who cannot join
- Patients' refusal to participate in clinical research
- Pregnant woman
- Breastfeeding woman
- A patient with a protective order
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg - Service de Réanimation médicale du NHC
Strasbourg, 67091
Ferhat MEZIANI, 03 69 55 10 24 ext. +33, ferhat.meziani@chru-strasbourg.fr
Hamid MERDJI, 03 69 55 11 23 ext. +33, hamid.merdji@chru-strasbourg.fr
About this study
Circulatory shocks (CS) are life-threatening, acute organ dysfunction. Advances in critical care medicine have decreased early hospital mortality, increasing the number of surviving patients. Regrettably, these survivors are at increased risk of new infections but also of cardiovascular disease.
The investigators hypothesize that CS with multi-organ dysfunction is associated with premature senescence of endothelial cells and immune cells and promotes endothelial thrombogenicity and immunosenescence leading to cardiovascular disease and secondary infections.
The aim of this work is therefore to evaluate the contribution of endothelial and leucocytes senescence to the occurrence of secondary events (infectious and cardiovascular) in patients with a CS. It will provide a better understanding of the pathogenesis of cardiovascular and immune diseases following a CS, likely to guide new management strategies to prevent their occurrence.
- Conditions
- Shock, Cardiovascular Diseases, Infection
- Being tested
- Biological samples will be done to evaluate the endothelial and leukocyte senescence.
- Keywords
- Shock, Cardiovascular Diseases, Infection
- Medical subject headings
- Shock, Cardiovascular Diseases, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samples will be done to evaluate the endothelial and leukocyte senescence.Biological
Noninvasive, reproducible, and sensitive methods to measure cardiac function, endothelial function, and arterial stiffness will be assess.
| Study group | Role | What they receive |
|---|---|---|
| Patients with circulatory shock | 500 patients with circulatory shock hospitalize in ICU will be prospectively included to assess the effect of this pathology on the senescence phenotype Receives: Biological: Biological samples will be done to evaluate the endothelial and leukocyte senescence. | |
| Healthy volunteers | 20 healthy volunteers will be included to assess the effect of no pathology on the senescence phenotype. Receives: Biological: Biological samples will be done to evaluate the endothelial and leukocyte senescence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main criterion will be the acquisition of a senescent phenotype concerning leukocytes and endothelial cells.
Biological samples will be done to evaluate the endothelial and leukocyte senescence.
Measured: 1 year
Secondary outcomes (1)
Incidence of cardiovascular events and secondary infection in hospitalized patients in intensive care unit for circulatory shock states
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start7 Jan 2019
- Primary completionFeb 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ferhat MEZIANI, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559569
- Sponsor's protocol ID
- 7031
- Acronym
- Seneshock
- Status last verified
- Mar 2025
- First submitted
- 17 May 2018
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chomel L, Vogt M, Demiselle J, Le Borgne P, Tschirhart M, Morandeau V, Merdji H, Miguet L, Helms J, Meziani F, Mauvieux L. TLRs1-10 Protein Expression in Circulating Human White Blood Cells during Bacterial and COVID-19 Infections. J Innate Immun. 2024;16(1):216-225. doi: 10.1159/000536593. Epub 2024 Mar 8.
PubMed 38461810
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Endothelial and Leukocyte Senescence in Circulatory Shock States
- ClinicalTrials.gov ID
- NCT03559569
- Acronym / sponsor ID
- Seneshock / 7031
- Conditions
- Shock, Cardiovascular Diseases, Infection
- Keywords
- Shock, Cardiovascular Diseases, Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 18 Jun 2018 (actual)
- 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.
Circulatory shocks (CS) are life-threatening, acute organ dysfunction. Advances in critical care medicine have decreased early hospital mortality, increasing the number of surviving patients. Regrettably, these survivors are at increased risk of new infections but also of cardiovascular disease.
The investigators hypothesize that CS with multi-organ dysfunction is associated with premature senescence of endothelial cells and immune cells and promotes endothelial thrombogenicity and immunosenescence leading to cardiovascular disease and secondary infections.
The aim of this work is therefore to evaluate the contribution of endothelial and leucocytes senescence to the occurrence of secondary events (infectious and cardiovascular) in patients with a CS. It will provide a better understanding of the pathogenesis of cardiovascular and immune diseases following a CS, likely to guide new management strategies to prevent their occurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with circulatory shock | – | Biological: Biological samples will be done to evaluate the endothelial and leukocyte senescence.500 patients with circulatory shock hospitalize in ICU will be prospectively included to assess the effect of this pathology on the senescence phenotype |
| Healthy volunteers | – | Biological: Biological samples will be done to evaluate the endothelial and leukocyte senescence.20 healthy volunteers will be included to assess the effect of no pathology on the senescence phenotype. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted in the intensive care unit of the "Nouvel Hôpital Civil de Strasbourg" for a circulatory shock will be included. Healthy volunteer will be included in our Clinical Investigation Center of the "Hôpitaux Universitaires de Strasbourg"
Key inclusion criteria (2 listed)
- Circulatory shock
- patient with health care insurance
Key exclusion criteria (4 listed)
- Patients' refusal to participate in clinical research
- Pregnant woman
- Breastfeeding woman
- A patient with a protective order
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 |
|---|---|---|
| Biological samples will be done to evaluate the endothelial and leukocyte senescence.Noninvasive, reproducible, and sensitive methods to measure cardiac function, endothelial function, and arterial stiffness will be assess. | Biological | Healthy volunteers, Patients with circulatory shock |
Primary outcome
The main criterion will be the acquisition of a senescent phenotype concerning leukocytes and endothelial cells.
Time frame: 1 year
Biological samples will be done to evaluate the endothelial and leukocyte senescence.
1 secondary outcome
Incidence of cardiovascular events and secondary infection in hospitalized patients in intensive care unit for circulatory shock states
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Derived from this study: PubMed 38461810Chomel L, Vogt M, Demiselle J, Le Borgne P, Tschirhart M, Morandeau V, Merdji H, Miguet L, Helms J, Meziani F, Mauvieux L. TLRs1-10 Protein Expression in Circulating Human White Blood Cells during Bacterial and COVID-19 Infections. J Innate Immun. 2024;16(1):216-225. doi: 10.1159/000536593. Epub 2024 Mar 8.
- Individual participant dataSharing planned: No
Related trials for Shock
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Hemophagocytic Lymphohistiocytosis (HLH) Evaluation and Research of Clinical, ImmUnoLogic and TranscriptomE Study
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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.
Ferhat MEZIANI principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock and Cardiovascular Diseases, run by University Hospital, Strasbourg, France at 1 site 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Morgane CLERC (03 88 11 68 55 ext. +33, morgane.clerc@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main criterion will be the acquisition of a senescent phenotype concerning leukocytes and endothelial cells. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03559569, which also lists 1 linked publication.
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 10 Mar 2025.