NCT01653977

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

Impact of Early Goal-directed Fluid Therapy in Hypovolemic 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 compares the safety and efficacy of GDTs using standard pressure-related parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in trauma patients requiring emergency surgery.

Conditions

• Hypovolemic Shock
• Trauma
• 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 central venous catheter and the 4-French artery catheter (femoral or humeral access site) will be connected to a dedicated haemodynamic monitor (Pulsiocath, PV2024L; Pulsion Medical Systems AG, Munich, Germany). The administration of fluid (250-500ml crystalloids or colloids) and 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: 2010-02-01
• Primary completion: 2014-06-01
• Completion: 2014-12-01
• First posted: 2012-07-31
• Last updated: 2016-05-13

Locations

1 site across 1 country: Switzerland