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

Primary Purpose

Septic Shock

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Volume expansion with gelofusine
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring norepinephrine infusion, under 48 hours in ICU

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Intensive Care Unit 20, Meilahti Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study arm, elevation of PEEP

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pulmonary function and oxygenation

Full Information

First Posted
April 2, 2013
Last Updated
April 4, 2013
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01827007
Brief Title
Assessment of Fluid Responsiveness by Elevation of PEEP in Patients With Septic Shock
Official Title
Assessment of Fluid Responsiveness by Elevation of PEEP in Patients With Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
norepinephrine infusion, under 48 hours in ICU

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study arm, elevation of PEEP
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Volume expansion with gelofusine
Primary Outcome Measure Information:
Title
Hemodynamic changes indicating fluid responsiveness assessed during elevation of PEEP. Change in mean arterial pressure or aortic velocity time integral.
Description
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
Time Frame
Measurement of hemodynamic variables at timepoints 0, 10,20, 60 minutes
Secondary Outcome Measure Information:
Title
Pulmonary function and oxygenation
Time Frame
0,10,20,60 minutes, at PEEP 10, 20,10 cmH2O and after fluid expansion PEEP10 cmH2O
Other Pre-specified Outcome Measures:
Title
blood gas sample, for assessment of pH, base excess and blood lactate
Time Frame
0, 60 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erika Wilkman, M.D
Organizational Affiliation
Anesthesia and Intensive Care, Department of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intensive Care Unit 20, Meilahti Hospital
City
Helsinki
State/Province
HUS
ZIP/Postal Code
00029
Country
Finland

12. IPD Sharing Statement

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

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