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Volemic Resuscitation in Sepsis and Septic Shock

NCT02565251 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-12-14

No results posted yet for this study

Summary

Severe sepsis and septic shock are among the leading causes of morbidity and mortality in patients admitted in the ICU, being responsible for approximately 200000 deaths/year in the USA and 150000 in Europe. Recognizing the early signs of sepsis and the different stages of this condition may lower the associated morbidity and mortality.

The hemodynamic profile of the septic shock is characterized by the presence of the distributive shock, on which we can add elements from the hypovolemic and cardiogenic shocks.

The objecive of this study is to optimize the volemic resuscitation of the severe septic and of the septic shock patient using two minimally invasive methods of hemdynamic monitoring which both use the same device (Edwards Lifescience). In the same time hemodinamic data will be colected by mesuring the inferior vena cava diameter.

Conditions

  • Hemodynamic Instability
  • Sepsis
  • Septic Shock

Interventions

DEVICE

Flotrac/Ev1000

Hemodynamic resusucitation guided by the data obtained from the monitorisation with Flotrac/Ev1000 device in the first two hours

DEVICE

Standard ICU monitorisation

Hemodynamic resusucitation guided by the data obtained from ICU standard hemodynamic monitoring (BP, CVP) in the first 2 hours

DEVICE

VolumeView/Ev1000

Hemodynamic resusucitation guided by the data obtained from the monitorisation with VolumeView/Ev1000 device in the next four hours

Sponsors & Collaborators

  • Iuliu Hatieganu University of Medicine and Pharmacy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Romania

Study Locations

More Related Trials

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 NCT02565251 on ClinicalTrials.gov