NCT00583687

Brief Summary

The purpose of this study is to compare changes of minimally invasive arterial pulse contour cardiac output with changes of intermittent and continuous thermodilution cardiac output by pulmonary artery catheter in hemodynamic unstable patients with rapid changing vascular tone (changing dosage of vasoactive drugs or inotropics, or volume challenge). Simultaneously, global parameters of oxygen delivery and consumption will be compared with regional flow parameters and tissue oxymetry (near infrared spectrometry and laser-Doppler). While continuous thermodilution cardiac output is used for patient management, pulse contour cardiac output, intermittent thermodilution cardiac output and tissue oxymetry is only used for monitoring.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 31, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

April 28, 2009

Status Verified

April 1, 2009

Enrollment Period

1.1 years

First QC Date

December 18, 2007

Last Update Submit

April 27, 2009

Conditions

Cardiac Output, HighCardiac Output, LowVasodilationVasoconstrictionHemodynamics

Keywords

Arterial pulse contour cardiac outputChanging vascular toneTissue OxymetryPrediction of Fluid Responsiveness

Outcome Measures

Primary Outcomes (1)

  • Changes of cardiac output measured by three different techniques during changes of vascular tone

    2 hours

Secondary Outcomes (2)

  • Prediction of fluid responsiveness with minimally invasive arterial pulse contour analysis in hemodynamic unstable patients.

    2 hours

  • Comparison of global parameters of oxygen delivery and consumption with local parameters of flow and tissue oxymetry during changes of vascular tone.

    2 hours

Interventions

Vigileo TM / Flotrac TM (Minimally invasive cardiac output system consisting of arterial line sensor and cardiac output monitor)DEVICE

Attachment of the arterial line sensor and pulse contour cardiac output monitor to the arterial line of the patient.

Also known as: Vigileo TM / Flotrac TM
Passive leg raisingOTHER

Passive leg raising for prediction of fluid responsiveness with arterial pulse contour analysis.

Volume challenge / Change of vasoactive drugs or inotropicsOTHER

Either a volume challenge (using colloids or crystalloids) or a change in the dosage of of vasoactive drugs or inotropics, or a combination of them, as proposed by the treating physician.

Inspectra TM/O-To-See TM (Tissue oxymetry with near infrared spectroscopy and laser-Doppler)DEVICE

Tissue oxymetry continuously measured with near infrared spectrometry and laser Doppler during the whole study period.

Also known as: Inspectra TM, O-To-See TM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for invasive hemodynamic monitoring with pulmonary artery catheter and arterial catheter
  • Hemodynamic instability (need for vasoactive drugs, inotropics or volume).

You may not qualify if:

  • Age \< 18.
  • Patient with contraindications for the placement of arterial cannula.
  • Patient with history or clinical findings of aortic valve regurgitation.
  • Atrial fibrillation.
  • Patient being treated with an intra-aortic balloon pump.
  • Limitation of therapy due to bad prognosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Intensive Care Medicine, University Hospital Inselspital, Berne

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Cardiac Output, HighCardiac Output, LowAneurysm

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Christoph C Ganter, M.D.

    Department of Intensive Care Medicine, University Hospital, Inselspital, Berne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 31, 2007

Study Start

December 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

April 28, 2009

Record last verified: 2009-04

Locations

CH(1)