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Completed

NCT Number: NCT01827007

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

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.

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intensive Care Unit 20, Meilahti Hospital

Helsinki, HUS, 00029, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Volume expansion with gelofusine

Other

Primary outcomes

  1. 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

  1. Pulmonary function and oxygenation

    Time frame: 0,10,20,60 minutes, at PEEP 10, 20,10 cmH2O and after fluid expansion PEEP10 cmH2O

Other outcomes

  1. blood gas sample, for assessment of pH, base excess and blood lactate

    Time frame: 0, 60 min

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Apr 9, 2013
Registry last updated
Apr 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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