Our hypothesis is that hemodynamic fluid resuscitation guided by dynamic parameters will improve outcome in patients with severe sepsis and septic shock, by limiting the deleterious effects of fluid overload.
To evaluate the efficacy of dynamic parameters versus static measures to guide fluid resuscitation we pretend to detect a 10% relative reduction in mortality. In addition, we pretend to observe an improvement on the length of resuscitation time, mechanical ventilation and vasopressor support-free days, ICU and hospital length of stay, organ failure and renal function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
952
● In preload-responsive patients defined by the following dynamic parameters: Patients fully adapted to mechanical ventilation\* and with sinus rhythm. 1. PPV \>12%. PPV: Pulse pressure variation PPV = (PPmax-PPmin)/ \[(PPmax+PPmin)/2\] x100 (during 5 respiratory cycles) 2. SVV \> 12% (15). SVV: Stroke volume variation * A tidal volume (Vt) ≥ 7-10cc/kg in mechanically ventilated (in a controlled mode - control volume or control pressure) and well-adapted patients without any inspiratory effort should be guaranteed. Fluid loading must be performed with crystalloids (1omL/Kg) or colloids (5ml/Kg) every 30 minutes until PPV-SVV \< 12%, while hypoperfusion signs are present. Continue resuscitation following Surviving Sepsis Campaign rules excluding more fluid administration (as described in the standard intervention once CVP\>12). ● Non-preload responsive patients (defined as PPV or SVV \< 12%) will resume the same protocol as responders when fluid response parameters are negative.
Fluid loading in patients with hypotension or elevated lactates until normalization of MAP (\> 65mmHg) or CVP \> 12mmHg. If CVP reaches \> 12 mmHg and MAP remains \< 65mmHg, norepinephrine should be started to reach MAP \> 65mmHg. Once MAP is restored, if hypoperfusion signs persist (elevated lactate or urine output \< 0.5mL/Kg/h), ScvO2/SvO2 must be measured. In order to reach a ScvO2 ≥70% or SVO2 ≥65%, consider giving blood transfusion if hemoglobin level (Hb) ≤ 7g/dL, and also consider dobutamine (initial dose 2,5 µg/kg/min, increased by 2,5 µg/kg/min every 30 min up to a maximum dose of 20 µg/kg/min, presence of arrhythmia, or FC\>110bpm). At that point, if hypoperfusion signs remain present, consider restart protocol from the beginning.
Area de Critics. Hospital de Sabadell
Sabadell, Barcelona, Spain
RECRUITINGMortality at 28 days
Time frame: 28 days after hospital admission
Length of resuscitation
* Vasopressor use and fluid load between 0h to 6h * Vasopressor use and fluid load between 7h to 72h
Time frame: 72 hours after protocol inclusion
Ventilator-free days
From 1 to 28 days over 28 days in a month.
Time frame: 28 days after admission
Vasopressor-free days
From 1 to 28 days over 28 days in a month.
Time frame: 28 days after admission
Organ failure-free days
Cardiovascular, CNS, renal, hepatic, coagulation abnormalities. From 1 to 28 days over 28 days in a month.
Time frame: 28 days after admission
ICU length of stay
Time frame: At ICU discharge (expected average 30 days after admission)
Hospital length of stay
Time frame: At hospital discharge (expected average 45 days after hospital admission)
Renal function evolution
Creatinin clearance will be calculated every day for the first 3 days (Cockroft-Gault formula).
Time frame: 3 days after study enrollment
Mortality at 3 months
Time frame: 3 months after admission
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