Volemic Resuscitation in Sepsis and Septic Shock

December 13, 2016 updated by: Platon Oana, Iuliu Hatieganu University of Medicine and Pharmacy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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 persistence of hypotension after adequate fluid load is the result of low vascular resistance and myocardial dysfunction and calls for certain specific correctional measures.

The diffrent hemodynamic profiles which can be found in the different stages of the septic shock and their dificult clinical identification led to the development of varoius hemodynamic monitoring techniques and devices. These techniques can be classified into invasive and minimally invasive, calibrated and uncalibrated. The major diffrences among these tecniques is the easyness of utilisation and the acuracy of the data obtained.

Inclusion Criteria: severe sepsis and septic shock (acording to the Sepsis Campaign 2013 crieria) patients with medical or surgical pathology which are admitted in the ICU unit in the first six hours after the onset of the severe sepsis/septic shock. The exclusion criteria of the patients are age less then 18 and more then 75, cardiac valvular pathology with hemodynamic importance, cardiac failure NYHA III și IV, primary or secondary pulmonary hypertension with hemodymanic impact with onset before the onset of the septic pathology,severe liver failure (Child-Pugh C), anuric renal failure, pregnant women, patient who refuse blood products adminitration, end-stage cancer.

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.

The primary outcome is the adecuacy of tissue perfusion at six hours (urinary output, blood pressure, lactate clearance, skin aspect). The secondary oucomes are duration of cardiovascular failure at the end of the 6 hours resuscitation period/ number of days, duration of respiratory failure (need of mechanical ventilation, number of days), duration of acute renal failure (need of dialysis) at ICU discharge/10/30/60 days, duration of ICU stay and in hospital stay, discharge status at 60 days (not discharged ,discharge to another acute care hospital, discharged to nursing home, discharged home ,other or unknown and all cause mortality at 60 days.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Romania
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400006
        • Recruiting
        • Cluj County Emenrgency Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: sepsis and septic shock (acording to the Sepsis Campaign 2016 crieria) patients with medical or surgical pathology which are admitted in the ICU unit in the first 12 hours after the onset of the sepsis/septic shock

Exclusion Criteria:

age less then 18 and more then 85 cardiac valvular pathology with hemodynamic importance cardiac failure NYHA IV primary or secondary pulmonary hypertension with hemodymanic impact with onset before the onset of the septic pathology Severe liver failure (Child-Pugh C) Anuric renal failure Pregnant women Patient who refuse blood products adminitration End-stage cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sepsis grup 1
Flotrac/Ev1000 in the first 2 hours and VolumeView/Ev1000 monitoring during the next 4 hours
Device: Flotrac/Ev1000
Hemodynamic resusucitation guided by the data obtained from the monitorisation with Flotrac/Ev1000 device in the first two hours
Device: VolumeView/Ev1000
Hemodynamic resusucitation guided by the data obtained from the monitorisation with VolumeView/Ev1000 device in the next four hours
Experimental: Sepsis grup 2
Hemodymanic resuscitation giuded by standard ICU monitorisation (BP, CVP) in the first 2 hours and VolumeView/Ev1000 monitoring during the next 4 hours
Device: VolumeView/Ev1000
Hemodynamic resusucitation guided by the data obtained from the monitorisation with VolumeView/Ev1000 device in the next four hours
Device: Standard ICU monitorisation
Hemodynamic resusucitation guided by the data obtained from ICU standard hemodynamic monitoring (BP, CVP) in the first 2 hours
Experimental: Soc septic grup 1
Flotrac/Ev1000 in the first 2 hours and VolumeView/Ev1000 monitoring during the next 4 hours
Device: Flotrac/Ev1000
Hemodynamic resusucitation guided by the data obtained from the monitorisation with Flotrac/Ev1000 device in the first two hours
Device: VolumeView/Ev1000
Hemodynamic resusucitation guided by the data obtained from the monitorisation with VolumeView/Ev1000 device in the next four hours
Experimental: Soc septic grup 2
Hemodymanic resuscitation giuded by standard ICU monitorisation (BP, CVP) in the first 2 hours andVolumeView/Ev1000 monitoring during the next 4 hours
Device: VolumeView/Ev1000
Hemodynamic resusucitation guided by the data obtained from the monitorisation with VolumeView/Ev1000 device in the next four hours
Device: Standard ICU monitorisation
Hemodynamic resusucitation guided by the data obtained from ICU standard hemodynamic monitoring (BP, CVP) in the first 2 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue perfusion at six hours (composite)
Time Frame: six hours
Tissue perfusion at six hours: urinary output, blood pressure, lactate clearance, skin aspect
six hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of cardiovascular failure
Time Frame: at the end of the 6 hours resuscitation period and one, two, six and twelve days
need of vasopressor support: at the end of the 6 hours resuscitation period and one, two, six and twelve days
at the end of the 6 hours resuscitation period and one, two, six and twelve days
Duration of respiratory failure
Time Frame: respiratory failure at oane day, two days, six days and twelve days
respiratory failure at oane day, two days, six days and twelve days
respiratory failure at oane day, two days, six days and twelve days
Duration of acute renal failure
Time Frame: at 5 days, at 10 days, at 30 days and at 60 days
Duration of acute renal failure (need of dialysis) at 5 days, at 10 days, at 30 days and at 60 days
at 5 days, at 10 days, at 30 days and at 60 days
Duration of ICU stay and in hospital stay
Time Frame: status at 5 days, at 10 days, at 30 days and at 60 days
Duration of ICU stay and in hospital stay
status at 5 days, at 10 days, at 30 days and at 60 days
Discharge status at 60 days
Time Frame: at 60 days
Discharge status at 60 days:Not discharged ,Discharge to another acute care hospital,Discharged to nursing home,Discharged home ,Other or unknown
at 60 days
all cause mortality at 60 days
Time Frame: 60 days
all cause mortality at 60 days
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

September 1, 2015

First Submitted That Met QC Criteria

September 30, 2015

First Posted (Estimate)

October 1, 2015

Study Record Updates

Last Update Posted (Estimate)

December 14, 2016

Last Update Submitted That Met QC Criteria

December 13, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWA00022929

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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