Perioperative Three Dimensional Right Ventricular Function

July 13, 2018 updated by: University Hospital Tuebingen
This study addresses the influence of anesthesia induction, ventilation and influence of cardiac surgical procedures and cardio-pulmonary-bypass on right ventricular function. Influence on patient outcome is also studied. Three dimensional echocardiography is applied.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

59

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
    • BW
      • Tubingen, BW, Germany, 72076
        • University Hospital Tübingen

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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult cardiac surgical patients

Description

Inclusion Criteria:

  • informed consent given
  • cardiac surgical procedure
  • left sided cardiac surgery or bypass surgery, ascending aortic surgery, assist device implantation

Exclusion Criteria:

  • pregnant patients
  • contraindication for transesophageal echocardiography

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time on Intensive Care Unit (ICU)
Time Frame: up to 60 days
Duration of ICU stay
up to 60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to hospital discharge
Time Frame: up to 120 days
Hospital Outcome
up to 120 days
Catecholamine dosages
Time Frame: up to 24 hours
after anesthesia induction, end of surgery, 12h and 24h after intensive care unit (ICU) admission
up to 24 hours
Catecholamine free days
Time Frame: up to 60 days
Catecholamine free days on ICU
up to 60 days
Hours on mechanical ventilation
Time Frame: up to 1440 hours
Duration of mechanical ventilation
up to 1440 hours
Organ failure during ICU stay
Time Frame: up to 60 days
Early organ failure (Lab tests: Creatinine, Bilirubin, Lactate, Thromboplastin Time)
up to 60 days

Collaborators and Investigators

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

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Harry Magunia, MD, University Hospital Tuebingen

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, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

June 6, 2016

First Submitted That Met QC Criteria

June 30, 2016

First Posted (Estimate)

July 1, 2016

Study Record Updates

Last Update Posted (Actual)

July 16, 2018

Last Update Submitted That Met QC Criteria

July 13, 2018

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnTubingen-RV

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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