Septic ShockPRODIASYS2NCT02918214
Prognostic Assessment of Diastolic and Systolic Left Ventricular Function in Septic Shock
An observational study of Septic Shock and Echocardiography, run by University Hospital, Limoges at 10 sites in France.
Trial summary
Sepsis induces a reversible systolic and diastolic cardiac dysfunction. The presence of a left ventricular (LV) diastolic dysfunction during septic shock could favor harmful volume overload. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Echocardiography, Diastolic Dysfunction
- How many people
- 440 participants
- Where
- 10 sitesFrance
- Study dates
- Jan 2017to Oct 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited in the ICU but also in Emergency Departments if they present with septic shock before ICU admission
Who may be able to join
- Patient hospitalized in ICU for septic shock:
- Documented or highly suspected infection (clinically or microbiologically)
- Causing an organ failure defined as an acute change in total SOFA score ≥ 2 points (baseline SOFA score can be assumed to be zero in the absence of pre-existing organ dysfunction)
- And low blood pressure (sBP < 90 mmHg or a decrease of more than 40 mmHg compared to baseline, or mBP < 65 mmHg) despite a fluid loading of 30 mL/kg (except if clinical or radiological sign of pulmonary fluid overload) requiring vasopressor infusion to maintain mBP > 65 mmHg
- And lactate level > 2 mmol/L
- Patient older than 18 years old affiliated to the French Social Security
- Non-opposition of the patient (or of its next-of-kin) to participate in the study
Who cannot join
- Ongoing dobutamine or epinephrine infusion
- Severe left valvular disease (severe stenosis, severe regurgitation ≥ grade 3)
- Constrictive pericarditis (invalidate the mitral tissue Doppler imaging)
- Pregnant women
- Patient with estimated life expectancy < 24h.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
University Hospital
Amiens, 80000
University Hospital
Brest, 29200
University Hospital
Limoges, 87042
CHU de Nancy
Nancy, 54511
CH d'Orleans
Orléans, 45000
Aphp - Ambroise Paré
Paris, 75010
CHU de Poitiers
Poitiers, 86021
Felix Guyon Hospital
Saint-Denis, 97405
University Hospital
Toulouse, 31000
University Hospital
Tours, 37000
About this study
Sepsis induces a reversible systolic and diastolic cardiac dysfunction. The presence of a left ventricular (LV) diastolic dysfunction during septic shock could favor harmful volume overload. Recently, a meta-analysis suggested a negative prognostic role of LV diastolic dysfunction in septic patients (Od Ratio: 1.82; 95%CI: 1.12 - 2.97; p = 0.02) but its external validity is hampered by the numerous limits and the heterogeneity of the studies. To date, a pathophysiological link between LV diastolic dysfunction associated with septic shock and the water balance (reflecting volume overload) remains to establish. In addition, small size studies reported an excess of mortality in patients with septic shock who were diagnosed with a high cardiac output. However, no large cohort has yet confirmed the negative prognostic role of a hyperkinetic hemodynamic profile at the initial phase of septic shock.
Read the detailed description
Consecutive patients diagnosed with septic shock will be followed daily using echocardiography from Day1 (first echocardiography performed within 12h after the diagnosis of septic shock) to Day3, after vasopressor discontinuation (Day end), and on Day28 or at hospital discharge (if occurs before Day28). Echocardiographic data will be anonymized and stored in DICOM format in a dedicated database for independent measurements by an expert in echocardiography blinded from the clinical data of the patients including vital status. Vital and biological parameters usually monitored for the management of septic shock will be collected at the time of each echocardiographic assessment. Patients' vital status will be collected on Day28. The potential influence of LV diastolic dysfunction and LV hyperkinesia on prognosis will be assessed.
- Conditions
- Septic Shock, Echocardiography, Diastolic Dysfunction, Hyperkinesia
- Keywords
- Septic Shock, echocardiography, diastolic dysfunction, Transthoracic, Transesophageal, hyperkinesia, prognosis
- Medical subject headings
- Shock, Septic, Hyperkinesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| echocardiography | Each patient will be hemodynamically assessed using echocardiography: Day1 defines the first echocardiography performed within the first 12 hours (ideally within the first 6 h) following the diagnosis of septic shock, Day2 and Day3 define the examination performed 24 to 36 h and 48 to 72 h later (guidance of treatment during the acute phase), Day end defines the examination performed after vasopressors cessation (end of hemodynamic failure). In addition, echocardiography will be performed on ICU discharge and on Day28 or on hospital discharge (whatever occurs first) to document potential reversibility of LV diastolic dysfunction. Transthoracic echocardiography will always first be performed and transesophageal echocardiography will be limited to ventilated patients without adequate surface echocardiographic image quality, under sedation and during the initial phase of septic shock (D1 to D3), according to the standards of care of participating centers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival at one month
Measured: Day 28
Secondary outcomes (2)
Daily water balance
The daily water balance (from Day1 to Day3 included) will be measured
Measured: Day 1 to Day 3
Cumulated water balances
The cumulated water balance on Day4 (sum of water balances recorded from Day1 to Day3 included) will be calculated
Measured: Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startJan 2017
- Primary completionOct 2019
- Study completionOct 2019
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 Septic ShockStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Tours
- Responsible party
- Sponsor
- Investigators
- Marine GOUDELIN, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918214
- Sponsor's protocol ID
- I16018 (PRODIASYS2)
- Acronym
- PRODIASYS2
- Status last verified
- Mar 2026
- First submitted
- 27 Sep 2016
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Vignon P, Charron C, Legras A, Musset F, Slama M, Prat G, Silva S, Vandroux D, Muller G, Levy B, Boissier F, Evrard B, Goudelin M, Mankikian S, Nay MA, Jabot J, Riu B, Bailly P, Maizel J, Leger J, Vieillard-Baron A; CRICS-TRIGGERSEP Network. Left ventricular diastolic dysfunction is prevalent but not associated with mortality in patients with septic shock. Intensive Care Med. 2025 Jan;51(1):94-105. doi: 10.1007/s00134-024-07748-2. Epub 2025 Jan 7.
PubMed 39774865
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Assessment of Diastolic and Systolic Left Ventricular Function in Septic Shock
- ClinicalTrials.gov ID
- NCT02918214
- Acronym / sponsor ID
- PRODIASYS2 / I16018 (PRODIASYS2)
- Conditions
- Septic Shock, Echocardiography, Diastolic Dysfunction, Hyperkinesia
- Keywords
- Septic Shock, echocardiography, diastolic dysfunction, Transthoracic, Transesophageal, hyperkinesia, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- University Hospital, Tours
- Study start
- Jan 2017 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 28 Sep 2016 (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.
Sepsis induces a reversible systolic and diastolic cardiac dysfunction. The presence of a left ventricular (LV) diastolic dysfunction during septic shock could favor harmful volume overload. Recently, a meta-analysis suggested a negative prognostic role of LV diastolic dysfunction in septic patients (Od Ratio: 1.82; 95%CI: 1.12 - 2.97; p = 0.02) but its external validity is hampered by the numerous limits and the heterogeneity of the studies. To date, a pathophysiological link between LV diastolic dysfunction associated with septic shock and the water balance (reflecting volume overload) remains to establish. In addition, small size studies reported an excess of mortality in patients with septic shock who were diagnosed with a high cardiac output. However, no large cohort has yet confirmed the negative prognostic role of a hyperkinetic hemodynamic profile at the initial phase of septic shock.
Detailed description
Consecutive patients diagnosed with septic shock will be followed daily using echocardiography from Day1 (first echocardiography performed within 12h after the diagnosis of septic shock) to Day3, after vasopressor discontinuation (Day end), and on Day28 or at hospital discharge (if occurs before Day28). Echocardiographic data will be anonymized and stored in DICOM format in a dedicated database for independent measurements by an expert in echocardiography blinded from the clinical data of the patients including vital status. Vital and biological parameters usually monitored for the management of septic shock will be collected at the time of each echocardiographic assessment. Patients' vital status will be collected on Day28. The potential influence of LV diastolic dysfunction and LV hyperkinesia on prognosis will be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| echocardiography | – | –Each patient will be hemodynamically assessed using echocardiography: Day1 defines the first echocardiography performed within the first 12 hours (ideally within the first 6 h) following the diagnosis of septic shock, Day2 and Day3 define the examination performed 24 to 36 h and 48 to 72 h later (guidance of treatment during the acute phase), Day end defines the examination performed after vasopressors cessation (end of hemodynamic failure). In addition, echocardiography will be performed on ICU discharge and on Day28 or on hospital discharge (whatever occurs first) to document potential reversibility of LV diastolic dysfunction. Transthoracic echocardiography will always first be performed and transesophageal echocardiography will be limited to ventilated patients without adequate surface echocardiographic image quality, under sedation and during the initial phase of septic shock (D1 to D3), according to the standards of care of participating centers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited in the ICU but also in Emergency Departments if they present with septic shock before ICU admission
Key inclusion criteria (7 listed)
- Patient hospitalized in ICU for septic shock:
- Patient older than 18 years old affiliated to the French Social Security
- Non-opposition of the patient (or of its next-of-kin) to participate in the study
Key exclusion criteria (5 listed)
- Ongoing dobutamine or epinephrine infusion
- Severe left valvular disease (severe stenosis, severe regurgitation ≥ grade 3)
- Constrictive pericarditis (invalidate the mitral tissue Doppler imaging)
- Pregnant women
- Patient with estimated life expectancy < 24h.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival
Time frame: Day 28
Survival at one month
2 secondary outcomes
Daily water balance
Time frame: Day 1 to Day 3
Cumulated water balances
Time frame: Day 4
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 19 Mar 2026.
- Results publication: PubMed 39774865Vignon P, Charron C, Legras A, Musset F, Slama M, Prat G, Silva S, Vandroux D, Muller G, Levy B, Boissier F, Evrard B, Goudelin M, Mankikian S, Nay MA, Jabot J, Riu B, Bailly P, Maizel J, Leger J, Vieillard-Baron A; CRICS-TRIGGERSEP Network. Left ventricular diastolic dysfunction is prevalent but not associated with mortality in patients with septic shock. Intensive Care Med. 2025 Jan;51(1):94-105. doi: 10.1007/s00134-024-07748-2. Epub 2025 Jan 7.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
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.
Marine GOUDELIN, MD principal investigator
University Hospital, Limoges
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and Echocardiography, run by University Hospital, Limoges at 10 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 7 inclusion and 5 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 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Survival (time frame: Day 28). 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 NCT02918214, 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 19 Mar 2026.