NCT02918214

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 440 (actual)
• Sponsor: University Hospital, Limoges · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Septic Shock
• Echocardiography
• Diastolic Dysfunction
• Hyperkinesia

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2016-09-28
• Last updated: 2026-03-19

Locations

10 sites across 1 country: France