Right Ventricular Dysfunction in Cardiac Surgery Patients

November 25, 2019 updated by: Matty Koopmans, Medical Centre Leeuwarden

Right Ventricular Dysfunction in Cardiac Surgery

To establish the correlation between echocardiographic parameters of the RV, measured with TEE and the right ventricular ejection fraction (thermodilution). To identify a time in the perioperative process when RV dysfunction occurs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Measurements with echocardiography were done during cardiac surgery to observe the right ventricular dysfunction in the perioperative process

Study Type

Observational

Enrollment (Actual)

15

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

  • Netherlands
      • Leeuwarden, Netherlands, 8934AD
        • Medical Centre Leeuwarden

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

15 cardiac surgery patients (elective, isolated aortic valve replacement or coronary artery bypass grafting in combination with aortic valve replacement) with a significant preoperative aortic valve stenosis (gradient>40mmHg and/or aortic valve area <1cm2)

Description

Inclusion Criteria:

  • cardiac surgery patients
  • elective, isolated aortic valve replacement or coronary artery bypass grafting in combination with aortic valve replacement

Exclusion Criteria:

  • age < 18

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
Intervention / Treatment
cardiac surgery patients
cardiac surgery patients with a significant peroperative aortic valve stenosis (gradient>40mmHg and/or aortic valve area <1cm2). During cardiac surgery measurements of right ventricular dysfunction were taken by echocardiography
Other: echocardiographic measurements
echocardiographic parameters of the RV, measured with TEE and the right ventricular ejection fraction (thermodilution)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The correlation between echocardiographic parameters of the RV, measured with TEE and the RVEF measured with the pulmonary artery catheter
Time Frame: during cardiac surgery
The correlation between echocardiographic parameters of the RV, measured with TEE and the RVEF measured with the pulmonary artery catheter.
during cardiac surgery

Collaborators and Investigators

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

Sponsor

Medical Centre Leeuwarden

Investigators

  • Principal Investigator: Christiaan Boerma, MD, MCL

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 (Actual)

September 6, 2017

Primary Completion (Actual)

June 20, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

June 8, 2017

First Submitted That Met QC Criteria

June 9, 2017

First Posted (Actual)

June 12, 2017

Study Record Updates

Last Update Posted (Actual)

November 26, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nWMO 220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

not available, patient data is anonym

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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