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CompletedNCT02918214PRODIASYS2Updated Mar 19, 2026

Prognostic Assessment of Diastolic and Systolic Left Ventricular Function in Septic Shock

An observational study in Septic Shock, Echocardiography and Diastolic Dysfunction, sponsored by University Hospital, Limoges. Completed at 10 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by University Hospital, Limoges · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
440
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Septic Shock
  • Echocardiography
  • Diastolic Dysfunction
  • Hyperkinesia

Keywords

  • Septic Shock
  • echocardiography
  • diastolic dysfunction
  • Transthoracic
  • Transesophageal
  • hyperkinesia
  • prognosis
03

In context

Shock, Septic

1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.

This study's enrollment of 440 is above the median of 108 across 406 observational studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

University Hospital, Limoges is the lead sponsor of 264 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients will be recruited in the ICU but also in Emergency Departments if they present with septic shock before ICU admission

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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 \< 24h.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
440 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Survival

    Survival at one month

    Time frame: Day 28

Secondary outcomes

  1. Daily water balance

    The daily water balance (from Day1 to Day3 included) will be measured

    Time frame: Day 1 to Day 3

  2. Cumulated water balances

    The cumulated water balance on Day4 (sum of water balances recorded from Day1 to Day3 included) will be calculated

    Time frame: Day 4

07

Study locations

10 sites
  • University Hospital
    Amiens, 80000, France
  • University Hospital
    Brest, 29200, France
  • University Hospital
    Limoges, 87042, France
  • CHU de Nancy
    Nancy, 54511, France
  • CH d'Orleans
    Orléans, 45000, France
  • Aphp - Ambroise Paré
    Paris, 75010, France
  • CHU de Poitiers
    Poitiers, 86021, France
  • Felix Guyon Hospital
    Saint-Denis, 97405, France
  • University Hospital
    Toulouse, 31000, France
  • University Hospital
    Tours, 37000, France
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02918214
Responsible party
Sponsor
First posted
Sep 28, 2016
Start date
Jan 2017
Primary completion
Oct 2019
Completion
Oct 2019
Last update
Mar 19, 2026

Study contacts

Marine GOUDELIN, MD
principal investigator · University Hospital, Limoges

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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