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

H

Helsinki University Central Hospital (HUCH)

Status

Completed

Conditions

Septic Shock

Treatments

Other: Volume expansion with gelofusine

Study type

Interventional

Funder types

Other

Identifiers

NCT01827007
HUS469/E6/05

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Study arm, elevation of PEEP
Experimental group
Treatment:
Other: Volume expansion with gelofusine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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