952
Participants
Start Date
March 31, 2013
Primary Completion Date
February 28, 2015
Study Completion Date
May 31, 2015
Dynamic-parameters-guided fluid management
"● 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."
Standard-guided-fluid management
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.
RECRUITING
Area de Critics. Hospital de Sabadell, Sabadell
Lead Sponsor
Corporacion Parc Tauli
OTHER