Clinical trial NCT03198611: Reversibility of Diastolic Disfunction in Septic Shock
Official title: Early Reversibility of Diastolic Disfunction as a Prognostic Factor in Septic Shock
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diastolic Dysfunction
Septic Shock
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Spanish Clinical Research Network - SCReN
First posted: 2017-06-26
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the ICU with diagnosis of septic shock, and stay longer than 48h

Brief summary: Objectives: To study the prognostic value of the evolution of diastolic function according to fluid balance in patients admitted to the ICU with a diagnosis of septic shock, in terms of mortality (ICU and hospital) and mortality at 90 days.

2.4. Secondary objectives: A) Incidence and reversibility of myocardial dysfunction (left ventricular systolic and diastolic) in septic shock.

B) Incidence and reversibility of diastolic dysfunction according to the echocardiographic criterion used.

C) Incidence and reversibility of right ventricular systolic dysfunction.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the ICU with diagnosis of septic shock, and stay longer than 48h

Exclusion Criteria:

* No echocardiographic window
* Fatal prognosis with do not resuscitate orders at admission
* Previous history of Ischemic cardiomyopathy
* Valvular prosthesis
* Advanced degree of valvular disorder
* Advanced degree of pericardial effusion

Primary outcomes:
measure: Mortality at 90 days
timeFrame: 90 days
Secondary outcomes:
measure: ICU mortality
timeFrame: 90 days
measure: In hospital mortality
timeFrame: 90 days
measure: Incidence of myocardial disfunction
timeFrame: During the first 24 hours of ICU admission
measure: Change in incidence of diastolic dysfunction
timeFrame: From first 24 hours of ICU admission until 48h, 72h and 7 days from admission
Other outcomes:
Locations:
city: Tortosa
country: Spain
facility: Hospital Verge de la Cinta
state: Tarragona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital del Vall d´Hebron
Study officials:
References:
citation: Suarez JC, Lopez P, Mancebo J, Zapata L. Diastolic dysfunction in the critically ill patient. Response from the authors. Med Intensiva. 2017 Apr;41(3):198. doi: 10.1016/j.medin.2016.12.008. Epub 2017 Mar 3. No abstract available. English, Spanish.
citation: Mahjoub Y, Benoit-Fallet H, Airapetian N, Lorne E, Levrard M, Seydi AA, Amennouche N, Slama M, Dupont H. Improvement of left ventricular relaxation as assessed by tissue Doppler imaging in fluid-responsive critically ill septic patients. Intensive Care Med. 2012 Sep;38(9):1461-70. doi: 10.1007/s00134-012-2618-9. Epub 2012 Jun 21.
citation: Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Alexandru Popescu B, Waggoner AD; Houston, Texas; Oslo, Norway; Phoenix, Arizona; Nashville, Tennessee; Hamilton, Ontario, Canada; Uppsala, Sweden; Ghent and Liege, Belgium; Cleveland, Ohio; Novara, Italy; Rochester, Minnesota; Bucharest, Romania; and St. Louis, Missouri. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. Eur Heart J Cardiovasc Imaging. 2016 Dec;17(12):1321-1360. doi: 10.1093/ehjci/jew082. Epub 2016 Jul 15. No abstract available.