Monitoring Resuscitation in Severe Sepsis and Septic Shock

NAUnknownINTERVENTIONAL
Enrollment

952

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

February 28, 2015

Study Completion Date

May 31, 2015

Conditions
Hemodynamics
Interventions
BEHAVIORAL

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."

BEHAVIORAL

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.

Trial Locations (1)

08208

RECRUITING

Area de Critics. Hospital de Sabadell, Sabadell

Sponsors
All Listed Sponsors
lead

Corporacion Parc Tauli

OTHER