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Clinical Trials/NCT01827007
NCT01827007
Completed
N/A

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

Helsinki University Central Hospital1 site in 1 country20 target enrollmentJanuary 2008
ConditionsSeptic Shock

Overview

Phase
N/A
Intervention
Not specified
Conditions
Septic Shock
Sponsor
Helsinki University Central Hospital
Enrollment
20
Locations
1
Primary Endpoint
Hemodynamic changes indicating fluid responsiveness assessed during elevation of PEEP. Change in mean arterial pressure or aortic velocity time integral.
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
February 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Erika Wilkman

M.D

Helsinki University Central Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Hemodynamic changes indicating fluid responsiveness assessed during elevation of PEEP. Change in mean arterial pressure or aortic velocity time integral.

Time Frame: Measurement of hemodynamic variables at timepoints 0, 10,20, 60 minutes

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

Secondary Outcomes

  • Pulmonary function and oxygenation(0,10,20,60 minutes, at PEEP 10, 20,10 cmH2O and after fluid expansion PEEP10 cmH2O)

Study Sites (1)

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