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

Septic Shock Clinical Trial

— PRODIASYS2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02918214
• Other study ID #: I16018 (PRODIASYS2)
• Status: Completed
• Start date: January 2017
• Est. completion date: October 2019

Study information

• Verified date: October 2019
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diastolic Dysfunction
• Echocardiography
• Hyperkinesia
• Hyperkinesis
• Septic Shock
• Shock
• Shock, Septic

Locations

Country	Name	City	State
France	University Hospital	Amiens
France	University Hospital	Brest
France	University Hospital	Limoges
France	CHU de Nancy	Nancy
France	CH d'Orleans	Orléans
France	Aphp - Ambroise Paré	Paris
France	CHU de Poitiers	Poitiers
France	Felix Guyon Hospital	Saint-Denis
France	University Hospital	Toulouse
France	University Hospital	Tours

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Limoges	University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Survival at one month	Day 28
Secondary	Daily water balance	The daily water balance (from Day1 to Day3 included) will be measured	Day 1 to Day 3
Secondary	Cumulated water balances	The cumulated water balance on Day4 (sum of water balances recorded from Day1 to Day3 included) will be calculated	Day 4