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

Completed

• Conditions: Echocardiography; Septic Shock; Diastolic Dysfunction; Hyperkinesia

• Registration Number: NCT02918214
• Lead Sponsor: University Hospital, Limoges

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.

Study Timeline

• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2016-09-27
• Study First Posted: 2016-09-28
• Study Start: 2017-01
• Status Verified: 2019-10
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Last Update Submitted: 2019-10-23
• Last Update Posted: 2019-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	Day 28	Survival at one month

Secondary Outcome Measures

Name	Time	Method
Cumulated water balances	Day 4	The cumulated water balance on Day4 (sum of water balances recorded from Day1 to Day3 included) will be calculated
Daily water balance	Day 1 to Day 3	The daily water balance (from Day1 to Day3 included) will be measured

Trial Locations

Locations (6)

CHU de Nancy; 🇫🇷 Nancy, France

CHU de Poitiers; 🇫🇷 Poitiers, France

Felix Guyon Hospital; 🇫🇷 Saint-Denis, France

University Hospital; 🇫🇷 Tours, France

CH d'Orleans; 🇫🇷 Orléans, France

Aphp - Ambroise Paré; 🇫🇷 Paris, France