- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02771080
Peak Systolic Global Longitudinal Strain and Low Cardiac Output Syndrome After Cardiac Surgery
November 22, 2016 updated by: Jean François Brichant, University of Liege
This is a retrospective observational study to assess the relationship between peak systolic global longitudinal strain measured on pre-cardiopulmonary bypass trans-esophageal echo images predicts post-operative low cardiac output syndrome defined as the need for an inotropic support during 24 hours or longer.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
275
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
Non-Probability Sample
Study Population
Adult patients undergoing on-pump elective or urgence cardiac surgery
Description
Inclusion Criteria:
- Cardiac surgery involving the use of cardiopulmonary bypass
- Availability of pre-cardiopulmonary bypass trans-oesophageal echo images allowing measurement of the peak systolic global longitudinal strain
Exclusion Criteria:
- Preoperative atrial fibrillation
- Preoperative critical state
- Emergent/salvage surgery
- Heart transplant surgery
- Left ventricular assist device implantation
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-operative low cardiac output syndrome
Time Frame: 30 days
|
Need for pharmacological inotropic support during 24 hours or more post-operatively
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Length of hospital stay
Time Frame: 30 days
|
30 days
|
|
Length of intensive care unit stay
Time Frame: 30 days
|
30 days
|
|
30-day or in hospital mortality
Time Frame: 30 days
|
30 days
|
|
duration of post-operative mechanical ventilation
Time Frame: 30 days
|
30 days
|
|
post-operative acute kidney injury
Time Frame: 30 days
|
30 days
|
|
Need for readmission to the intensive care
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
June 1, 2016
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
May 11, 2016
First Submitted That Met QC Criteria
May 11, 2016
First Posted (Estimate)
May 12, 2016
Study Record Updates
Last Update Posted (Estimate)
November 23, 2016
Last Update Submitted That Met QC Criteria
November 22, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHULgstrain
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.