Clinical trial NCT02918214: Prognostic Assessment of Diastolic and Systolic Left Ventricular Function in Septic Shock
Official title: Prognostic Assessment of Diastolic and Systolic Left Ventricular Function in Septic Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Shock
Echocardiography
Diastolic Dysfunction
Hyperkinesia
Keywords: Septic Shock
echocardiography
diastolic dysfunction
Transthoracic
Transesophageal
hyperkinesia
prognosis
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
Collaborators: name: University Hospital, Tours
First posted: 2016-09-28
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Survival
timeFrame: Day 28
Secondary outcomes:
measure: Daily water balance
timeFrame: Day 1 to Day 3
measure: Cumulated water balances
timeFrame: Day 4
Other outcomes:
Locations:
city: Amiens
country: France
facility: University Hospital
city: Brest
country: France
facility: University Hospital
city: Limoges
country: France
facility: University Hospital
city: Nancy
country: France
facility: CHU de Nancy
city: Orléans
country: France
facility: CH d'Orleans
city: Paris
country: France
facility: Aphp - Ambroise Paré
city: Poitiers
country: France
facility: CHU de Poitiers
city: Saint-Denis
country: France
facility: Felix Guyon Hospital
city: Toulouse
country: France
facility: University Hospital
city: Tours
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Limoges
name: Marine GOUDELIN, MD
role: PRINCIPAL_INVESTIGATOR
References: