Sepsis Clinical Trial
Official title:
Volemic Resuscitation in Sepsis and Septic Shock
Severe sepsis and septic shock are among the leading causes of morbidity and mortality in
patients admitted in the ICU, being responsible for approximately 200000 deaths/year in the
USA and 150000 in Europe. Recognizing the early signs of sepsis and the different stages of
this condition may lower the associated morbidity and mortality.
The hemodynamic profile of the septic shock is characterized by the presence of the
distributive shock, on which we can add elements from the hypovolemic and cardiogenic
shocks.
The objecive of this study is to optimize the volemic resuscitation of the severe septic and
of the septic shock patient using two minimally invasive methods of hemdynamic monitoring
which both use the same device (Edwards Lifescience). In the same time hemodinamic data will
be colected by mesuring the inferior vena cava diameter.
Severe sepsis and septic shock are among the leading causes of morbidity and mortality in
patients admitted in the ICU, being responsible for approximately 200000 deaths/year in the
USA and 150000 in Europe . Recognizing the early signs of sepsis and the different stages of
this condition may lower the associated morbidity and mortality.
The hemodynamic profile of the septic shock is characterized by the presence of the
distributive shock, on which we can add elements from the hypovolemic and cardiogenic
shocks. The persistence of hypotension after adequate fluid load is the result of low
vascular resistance and myocardial dysfunction and calls for certain specific correctional
measures.
The diffrent hemodynamic profiles which can be found in the different stages of the septic
shock and their dificult clinical identification led to the development of varoius
hemodynamic monitoring techniques and devices. These techniques can be classified into
invasive and minimally invasive, calibrated and uncalibrated. The major diffrences among
these tecniques is the easyness of utilisation and the acuracy of the data obtained.
Inclusion Criteria: severe sepsis and septic shock (acording to the Sepsis Campaign 2013
crieria) patients with medical or surgical pathology which are admitted in the ICU unit in
the first six hours after the onset of the severe sepsis/septic shock. The exclusion
criteria of the patients are age less then 18 and more then 75, cardiac valvular pathology
with hemodynamic importance, cardiac failure NYHA III și IV, primary or secondary pulmonary
hypertension with hemodymanic impact with onset before the onset of the septic
pathology,severe liver failure (Child-Pugh C), anuric renal failure, pregnant women, patient
who refuse blood products adminitration, end-stage cancer.
The objecive of this study is to optimize the volemic resuscitation of the severe septic and
of the septic shock patient using two minimally invasive methods of hemdynamic monitoring
which both use the same device (Edwards Lifescience). In the same time hemodinamic data will
be colected by mesuring the inferior vena cava diameter.
The primary outcome is the adecuacy of tissue perfusion at six hours (urinary output, blood
pressure, lactate clearance, skin aspect). The secondary oucomes are duration of
cardiovascular failure at the end of the 6 hours resuscitation period/ number of days,
duration of respiratory failure (need of mechanical ventilation, number of days), duration
of acute renal failure (need of dialysis) at ICU discharge/10/30/60 days, duration of ICU
stay and in hospital stay, discharge status at 60 days (not discharged ,discharge to another
acute care hospital, discharged to nursing home, discharged home ,other or unknown and all
cause mortality at 60 days.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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