NCT01747057

Monitoring Resuscitation in Severe Sepsis and Septic Shock

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 952 (estimated)
• Sponsor: Corporacion Parc Tauli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hemodynamics

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-02-01
• Completion: 2015-05-01
• First posted: 2012-12-11
• Last updated: 2014-02-13

Locations

1 site across 1 country: Spain