NCT01654003

Impact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency Surgery

Impact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency Surgery. A Prospective, Randomised, Open Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study wants to compared the safety and efficacy of GDTs using standard pressure-related parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in septic patients requiring emergency surgery.

Conditions

• Severe Sepsis
• Emergency
• Surgery

Interventions

Type	Name	Description
OTHER	CONTROL	In the CONTROL group, the administration of fluid (250-500ml crystalloids or colloids) and cardiovascular supportive drugs will be guided to maintain standard pressure-related parameters within a normal range: MAP \> 65mmHg, HR \< 90/min, CVP \>8-12\< cm H20, urinary output \> 0.5 ml/kg/h. In line with the conventional approach, other physiological parameters will also be targeted: T° \> 35.5°C, Sp02 \> 95%, lactate \< 2.5 mmol/L, normalisation of the BE. The maximal infused volume of hydroxyethyl starch (Voluven®) will be 33 ml/kg.
OTHER	OPTIMIZED	In the OPTIMIZED group, the haemodynamic monitor (Pulsiocath)will help to a goal-directed administration of fluid (250-500ml crystalloids or colloids).The cardiovascular supportive drugs will be guided by an algorithm taking into account standard parameters (HR, MAP, lactate, Hb), as well as static and dynamic volumetric parameters (SVI, CI, GEDVI, EVLWI, SVV, PPV, PVI).

Timeline

• Start date: 2010-04-01
• Primary completion: 2014-06-01
• Completion: 2014-12-01
• First posted: 2012-07-31
• Last updated: 2016-05-13

Locations

2 sites across 1 country: Switzerland