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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01827007
• Other study ID #: HUS469/E6/05
• Status: Completed
• Phase: N/A
• First received: April 2, 2013
• Last updated: April 4, 2013
• Start date: January 2008
• Est. completion date: February 2013

Study information

• Verified date: April 2013
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Other:
• Volume expansion with gelofusine

Locations

Country	Name	City	State
Finland	Intensive Care Unit 20, Meilahti Hospital	Helsinki	HUS

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	blood gas sample, for assessment of pH, base excess and blood lactate		0, 60 min	No
Primary	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	Measurement of hemodynamic variables at timepoints 0, 10,20, 60 minutes	No
Secondary	Pulmonary function and oxygenation		0,10,20,60 minutes, at PEEP 10, 20,10 cmH2O and after fluid expansion PEEP10 cmH2O	No