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

NCT ID: NCT01827007

Last Updated: 2013-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2013-02-28

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study arm, elevation of PEEP

Group Type: EXPERIMENTAL

Volume expansion with gelofusine

Intervention Type: OTHER

Interventions

Volume expansion with gelofusine

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Erika Wilkman

M.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erika Wilkman, M.D

Role: PRINCIPAL_INVESTIGATOR

Anesthesia and Intensive Care, Department of Surgery

Locations

Intensive Care Unit 20, Meilahti Hospital

Helsinki, HUS, Finland

Countries

Finland

Other Identifiers

HUS469/E6/05

Identifier Type: -

Identifier Source: org_study_id