Prediction of Volume Responsiveness in Presence of Left Ventricular Diastolic Dysfunction

May 7, 2015 updated by: Ole Broch, MD, University Hospital Schleswig-Holstein

Prediction of Fluid Responsiveness in Presence of Diastolic Dysfunction

The ability of the global end-diastolic volume index (GEDVI), stroke volume variation (SVV) and pulse pressure variation (PPV) for prediction of fluid responsiveness in presence of left ventricular diastolic dysfunction is still unknown. The aim of the present study was to challenge the predictive power of GEDVI, SVV and PPV in cardiac surgery patients undergoing aortic valve replacement.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

All patients receive premedication with midazolam 7.5 mg p.o.. After induction of anesthesia with sufentanil (0.5 µg/kg) and propofol (1.5 mg/kg), orotracheal intubation is facilitated with rocuronium (0.6 mg/kg). Anesthesia is maintained with sufentanil (1 µg/kg/h) and propofol (3 mg/kg/h) and patients are ventilated with an oxygen/air mixture in volume-controlled mode, using a tidal volume of 8 ml/kg related to the ideal body weight. Positive end-expiratory pressure is set at 5 cmH2O. Continuous monitoring is performed including electrocardiogram, radial arterial pressure catheter and a central venous catheter in the right or left internal jugular vein. Before placement of a transpulmonary thermodilution catheter a transesophageal echocardiography (TOE) is performed. TOE is used to detect diastolic dysfunction of the left ventricle and to exclude right ventricular dysfunction. In presence of left ventricular dysfunction a transpulmonary thermodilution catheter is placed in the femoral artery and connected to a PiCCO2 monitor (PiCCO2, Pulsion Medical Systems, Munich, Germany). Additionally capnography, urine output, temperature (blood, bladder and nasopharyngeal), airway pressure, and pulse oximetry are recorded.

Before starting operation a passive leg raising is performed. The passive leg raising maneuver (PLR) involves a leg elevation up to 45° with the trunk in a horizontal position and was performed to induce hemodynamic effects by a volume challenge, turning unstressed blood volume to stressed volume proportional to body size. In case of an increase of stroke volume index (SVI) >15% during PLR, patients were defined as responders.

All patients were studied with no changes in anesthesia management. Measurements of SVI, GEDVI, SVV and PPV are performed before, during and after PLR. Thereafter, patients receive a fluid Bolus of 500 ml crystalloids. Again, measurements are performed before and after fluid replacement.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Ole Broch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients > 18 yrs of age
  • Patients with a left ventricular ejection fraction ≥0.5
  • Patients with left ventricular diastolic dysfunction.

Exclusion Criteria:

  • Emergency procedures
  • Right ventricular dysfunction
  • Hemodynamic instability requiring pharmacologic Support
  • Ongoing arrhythmia
  • Intracardiac Shunts
  • Severe mitral stenosis or insufficiency
  • Aortic aneurysm > 4 cm
  • Use of an artificial left ventricular assist device or intra - aortic balloon pump.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Passive leg raising
Other: passive leg raising
The passive leg raising maneuver (PLR) involves a leg elevation up to 45° with the trunk in a horizontal position and is performed to induce hemodynamic effects by a volume challenge, turning unstressed blood volume to stressed volume proportional to body size.
Other: premedication
Other: premedication
patients receive premedication with midazolam 7.5 mg p.o.
Other: intubation and mechanical ventilation
Other: intubation and mechanical ventilation
After induction of anesthesia with sufentanil (0.5 µg/kg) and propofol (1.5 mg/kg), orotracheal intubation is facilitated with rocuronium (0.6 mg/kg). Anesthesia is maintained with sufentanil (1 µg/kg/h) and propofol (3 mg/kg/h) and patients are ventilated with an oxygen/air mixture in volume-controlled mode, using a tidal volume of 8 ml/kg related to the ideal body weight. Positive end-expiratory pressure is set at 5 cmH2O.
Other: central venous catheter
Other: central venous catheter
a central venous catheter in the right or left internal jugular vein.
Other: arterial catheter
Continuous monitoring is performed including electrocardiogram, radial arterial pressure catheter
Other: arterial catheter
Continuous monitoring is performed including electrocardiogram, radial arterial pressure catheter
Other: transesophageal echocardiography
Other: transesophageal echocardiography
Before placement of a transpulmonary thermodilution catheter a transesophageal echocardiography (TOE) is performed. TOE is used to detect diastolic dysfunction of the left ventricle and to exclude right ventricular dysfunction.
Other: transpulmonary thermodilution catheter
Other: transpulmonary thermodilution catheter
In presence of left ventricular dysfunction a transpulmonary thermodilution catheter is placed in the femoral artery and connected to a PiCCO2 monitor (PiCCO2, Pulsion Medical Systems, Munich, Germany).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase in stroke volume index (SVI) >15%
Time Frame: Patients will be obtained until the end of the operation, an expected average of 5 hours
In presence of an increase of SVI >15% during PLR and/or 500 ml crystalloids, patients are defined as responders.
Patients will be obtained until the end of the operation, an expected average of 5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Investigators

  • Principal Investigator: Ole Broch, MD, Consultant anesthetist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

April 28, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Estimate)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 7, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AZ-139

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemodynamics

Clinical Trials on passive leg raising

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe