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

Sponsor
Helsinki University Central Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01827007
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
61
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Volume expansion with gelofusine
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Assessment of Fluid Responsiveness by Elevation of PEEP in Patients With Septic Shock
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Feb 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study arm, elevation of PEEP

Other: Volume expansion with gelofusine

Outcome Measures

Primary Outcome Measures

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

  1. Pulmonary function and oxygenation [0,10,20,60 minutes, at PEEP 10, 20,10 cmH2O and after fluid expansion PEEP10 cmH2O]

Other Outcome Measures

  1. blood gas sample, for assessment of pH, base excess and blood lactate [0, 60 min]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Intensive Care Unit 20, Meilahti Hospital Helsinki HUS Finland 00029

Sponsors and Collaborators

  • Helsinki University Central Hospital

Investigators

  • Principal Investigator: Erika Wilkman, M.D, Anesthesia and Intensive Care, Department of Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Erika Wilkman, M.D, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01827007
Other Study ID Numbers:
  • HUS469/E6/05
First Posted:
Apr 9, 2013
Last Update Posted:
Apr 9, 2013
Last Verified:
Apr 1, 2013
Keywords provided by Erika Wilkman, M.D, Helsinki University Central Hospital
norepinephrine infusion
under 48 hours in ICU
Additional relevant MeSH terms:
Shock, Septic
Shock
Polygeline

Study Results

No Results Posted as of Apr 9, 2013