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

NCT01827007 | Completed

• 1 other identifier: HUS469/E6/05
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

norepinephrine infusion; under 48 hours in ICU

Outcome Measures

Primary Outcomes (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 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

Secondary Outcomes (1)

• Pulmonary function and oxygenation

  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

  0, 60 min

Study Arms (1)

Study arm, elevation of PEEP

EXPERIMENTAL

Other: Volume expansion with gelofusine

Interventions

Volume expansion with gelofusine OTHER

Study arm, elevation of PEEP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Intensive Care Unit 20, Meilahti Hospital

Helsinki, HUS, 00029, Finland

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Polygeline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Polymers; Macromolecular Substances; Peptides; Amino Acids, Peptides, and Proteins; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Erika Wilkman, M.D

  Anesthesia and Intensive Care, Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 9, 2013
• Study Start: January 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: April 9, 2013

Record last verified: 2013-04

Locations

FI (1)