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

NCT01653977 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-05-13

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Gordana Pavlovic, MD · University Hospital, Geneva

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2014-06-30
Completion
2014-12-31

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01653977 on ClinicalTrials.gov