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

NCT02918214 | Completed

• 1 other identifier: I16018 (PRODIASYS2)
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Septic Shock; Echocardiography; Hyperkinesia; Diastolic Dysfunction

Keywords

Septic Shock; echocardiography; diastolic dysfunction; Transthoracic; Transesophageal; hyperkinesia; prognosis

Outcome Measures

Primary Outcomes (1)

• Survival

  Survival at one month

  Day 28

Secondary Outcomes (2)

• Daily water balance

  Day 1 to Day 3

• Cumulated water balances

  Day 4

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Limoges: lead
• University Hospital, Tours: collaborator

Study Sites (10)

University Hospital

Amiens, 80000, France

Location

University Hospital

Brest, 29200, France

Location

University Hospital

Limoges, 87042, France

Location

CHU de Nancy

Nancy, 54511, France

Location

CH d'Orleans

Orléans, 45000, France

Location

Aphp - Ambroise Paré

Paris, 75010, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

Felix Guyon Hospital

Saint-Denis, 97405, France

Location

University Hospital

Toulouse, 31000, France

Location

University Hospital

Tours, 37000, France

Location

Related Publications (1)

• 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.

  PMID: 39774865 RESULT

MeSH Terms

Conditions

Shock, Septic; Hyperkinesis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Marine GOUDELIN, MD

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: September 28, 2016
• Study Start: January 1, 2017
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)