EVENT - Evaluation of the Influence of hTEE (EVENT)

January 25, 2014 updated by: Michael Sander, Charite University, Berlin, Germany

Retrospective Matched Pair Analyses for Evaluating the Influence of Hemodynamically Focussed Transesophageal Echocardiography (hTEE) on Postoperative Outcome in Cardiosurgery Patients

Compromised tissue oxygenation during surgery may negatively influence patient outcome. Primary cause of insufficient tissue oxygenation is reduced cardiac output due to hypovolemia and/or reduced cardiac contractility. In cardiac surgery patients especially, postoperative pericardia effusion and/or tamponade may further compromise cardiac function. Today, hemodynamically instable patients are often monitored by means of pulmonal artery catheters or transpulmonary thermodilution. However, these methods only allow quantification of functional limitations. Underlying causes may be investigated by relatively recent technology through hemodynamically focussed transesophageal echocardiography (ClariTEE(R) ImaCor) that also provide the possibility of continuous monitoring. It has been reported that a training program consisting of six hours may enable physicians who are unexperienced in the field of echocardiography to apply this new method. Up to now, there is no evidence whether this methods is associated with improved postoperative outcome.

Therefore we hypothesize that continuous hemodynamically focussed transesophageal echocardiography positively influences patient outcome (primary hypothesis). Furthermore, its application may decrease hospital expenses (secondary hypothesis).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

36

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
      • Berlin, Germany, 10117
        • Charité Universitätsmedizin Berin

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

Sampling Method

Probability Sample

Study Population

Patients undergoing cardiac surgery followed by postoperative observation on an ICU of the anaesthesiology department of the Charité hospital

Description

Inclusion Criteria:

  • elective, cardiac surgery
  • hemodynamic instability or placement of hTEE/PICCO (Pulse Contour Continuous Cardiac Output) /PAC (Pulmonary Arterial Catheter) within 12 hours of ICU admission

Exclusion Criteria:

  • pregnant/breastfeeding women

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

Cohorts and Interventions

Group / Cohort
Study group
Patients monitored with hemodynamically focussed transesophageal echocardiography (placement within 12 hours of ICU admission)
Control Group
Patients receiving conventional monitoring (e.g. transpulmonary thermodilution)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cumulative dosage of catecholamine application
Time Frame: three days beginning upon placement of device
three days beginning upon placement of device

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
degree and duration of other vasoactive substances
Time Frame: degree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively)
i.e. epinephrine, levosimendan, dopamine, nitroglycerine, nitroprusside
degree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively)
fluid balance
Time Frame: day 1, 2 and 3, beginning upon placement of device (or icu admission in control patients, respectively)
day 1, 2 and 3, beginning upon placement of device (or icu admission in control patients, respectively)
degree and duration of lactate acidosis
Time Frame: degree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively)
maximum lactate level, date/time of maximum lactate level, first date/time when lactate <20
degree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively)
duration of postoperative ventilation
Time Frame: first postoperative day until extubation (2 days on average)
first postoperative day until extubation (2 days on average)
incidence of renal failure
Time Frame: three days beginning upon placement of device (or icu admission in control patients, respectively)
analysis of creatinine plasma level
three days beginning upon placement of device (or icu admission in control patients, respectively)
incidence of hemodialysis
Time Frame: three days beginning upon placement of device (or icu admission in control patients, respectively)
three days beginning upon placement of device (or icu admission in control patients, respectively)
length of hospital stay
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
in-hospital mortality
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
cost of hospital stay
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

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

October 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

January 19, 2014

First Submitted That Met QC Criteria

January 25, 2014

First Posted (Estimate)

January 28, 2014

Study Record Updates

Last Update Posted (Estimate)

January 28, 2014

Last Update Submitted That Met QC Criteria

January 25, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA1/249/13

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.

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