Right Ventricular Dysfunction in Cardiac Surgery Patients
1 other identifier
observational
15
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2017
Shorter than P25 for all trials
1 active site
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
First Submitted
Initial submission to the registry
June 8, 2017
CompletedFirst Posted
Study publicly available on registry
June 12, 2017
CompletedStudy Start
First participant enrolled
September 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedNovember 26, 2019
November 1, 2019
10 months
June 8, 2017
November 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The correlation between echocardiographic parameters of the RV, measured with TEE and the RVEF measured with the pulmonary artery catheter
The correlation between echocardiographic parameters of the RV, measured with TEE and the RVEF measured with the pulmonary artery catheter.
during cardiac surgery
Study Arms (1)
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
Interventions
echocardiographic parameters of the RV, measured with TEE and the right ventricular ejection fraction (thermodilution)
Eligibility Criteria
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)
You may qualify if:
- cardiac surgery patients
- elective, isolated aortic valve replacement or coronary artery bypass grafting in combination with aortic valve replacement
You may not qualify if:
- age \< 18
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Centre Leeuwarden
Leeuwarden, 8934AD, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christiaan Boerma, MD
MCL
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MSc
Study Record Dates
First Submitted
June 8, 2017
First Posted
June 12, 2017
Study Start
September 6, 2017
Primary Completion
June 20, 2018
Study Completion
June 30, 2018
Last Updated
November 26, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share
not available, patient data is anonym