Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02771080
Other study ID # CHULgstrain
Secondary ID
Status Completed
Phase N/A
First received May 11, 2016
Last updated November 22, 2016
Start date June 2016
Est. completion date September 2016

Study information

Verified date June 2016
Source University Hospital of Liege
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 275
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Procedure:
Cardiac surgery


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital of Liege

Outcome

Type Measure Description Time frame Safety issue
Primary Post-operative low cardiac output syndrome Need for pharmacological inotropic support during 24 hours or more post-operatively 30 days No
Secondary Length of intensive care unit stay 30 days No
Secondary Length of hospital stay 30 days No
Secondary 30-day or in hospital mortality 30 days No
Secondary duration of post-operative mechanical ventilation 30 days No
Secondary post-operative acute kidney injury 30 days No
Secondary Need for readmission to the intensive care 30 days No