Peak Systolic Global Longitudinal Strain and Low Cardiac... | NCT02771080

Studies
Peak Systolic Global Longitudinal Strain and Low Cardiac Output Syndrome After Cardiac Surgery

NCT02771080

Sponsor

University of Liege

Status

Completed

Last Update Posted

Nov 23, 2016Estimated

Enrollment

275Actual

Phase

Not provided

Conditions

Low Cardiac Output Syndrome After Adult Cardiac Surgery

Interventions

Cardiac surgery

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

May 11, 2016

First Submission Date that Met QC Criteria

May 11, 2016

First Posted Date

May 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2016

Last Update Posted Date

Nov 23, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

275Actual

Name	Type	Description	Arm Group Labels	Other Names
Cardiac surgery	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-operative low cardiac output syndrome	Need for pharmacological inotropic support during 24 hours or more post-operatively	30 days

Secondary Outcomes

Measure	Description	Time Frame
Length of intensive care unit stay		30 days
Length of hospital stay		30 days
30-day or in hospital mortality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients undergoing on-pump elective or urgence cardiac surgery

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29116972	Derived	Amabili P, Benbouchta S, Roediger L, Senard M, Hubert MB, Donneau AF, Brichant JF, Hans GA. Low Cardiac Output Syndrome After Adult Cardiac Surgery: Predictive Value of Peak Systolic Global Longitudinal Strain. Anesth Analg. 2018 May;126(5):1476-1483. doi: 10.1213/ANE.0000000000002605.

ID	Term
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019616	Thoracic Surgical Procedures