Assessment of Fluid Responsiveness by Elevation of PEEP in Patients With Septic Shock

Study Overview
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Brief Summary
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The aim of the study is to evaluate whether fluid responsiveness of the critically ill patient can be assessed by analysing the PEEP-induced hemodynamic effects to systolic blood pressure, pulse pressure, aortic blood flow, aortic time-velocity integral and left ventricular end diastolic area measured with transesophageal echocardiography (PEEP-test). The chances are compared to increase of CI after volume expansion (gold standard). In clinical practise, it would be especially relevant if PEEP-induced changes in arterial pressure variations could be used in evaluation of volume status and fluid responsiveness. However, as ECHO-derived variables are used in greater extent to guide the treatment with inappropriate evidence, the simultaneous registration of ECHO-derived hemodynamic measurements is essential in the study design.

Official Title
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Assessment of Fluid Responsiveness by Elevation of PEEP in Patients With Septic Shock

Conditions
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Septic Shock

Intervention / Treatment
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* Other: Volume expansion with gelofusine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:• Written informed consent by patient or relative Time in ICU < 48 hours Septic shock Pulmonary artery catheter and radial arterial catheter Age 18 - 75 years Sinus rhythm Need for norepinephrine over 0.1 ug/kg/min but otherwise hemodynamically stable i.e no need to change the dose over the last 15min period before the study Mechanical ventilation with sedation Pwcp <18 mmHg Exclusion Criteria: Contraindication to elevation of PEEP ( elevated intracranial pressure, pulmonary hypertension or other contraindication ) Contraindication to fluid challenge Contraindication to TEE Previous heart failure, heart valve stenosis of insufficiency

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm, elevation of PEEP<br> | Other: Volume expansion with gelofusine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic changes indicating fluid responsiveness assessed during elevation of PEEP. Change in mean arterial pressure or aortic velocity time integral. | Measurement of hemodynamic variables using a pulmonary catheter and transesophageal echocardiography at baseline PEEP 10, during elevation of PEEP and after volume challenge at PEEP 10 cmH2O | Measurement of hemodynamic variables at timepoints 0, 10,20, 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function and oxygenation |  | 0,10,20,60 minutes, at PEEP 10, 20,10 cmH2O and after fluid expansion PEEP10 cmH2O | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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norepinephrine infusion, under 48 hours in ICU