NCT02771080

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Status
completed

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

May 11, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
20 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 23, 2016

Status Verified

June 1, 2016

Enrollment Period

3 months

First QC Date

May 11, 2016

Last Update Submit

November 22, 2016

Conditions

Low Cardiac Output Syndrome After Adult Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • Post-operative low cardiac output syndrome

    Need for pharmacological inotropic support during 24 hours or more post-operatively

    30 days

Secondary Outcomes (6)

  • Length of intensive care unit stay

    30 days

  • Length of hospital stay

    30 days

  • 30-day or in hospital mortality

    30 days

  • duration of post-operative mechanical ventilation

    30 days

  • post-operative acute kidney injury

    30 days

  • +1 more secondary outcomes

Interventions

Cardiac surgeryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing on-pump elective or urgence cardiac surgery

You may qualify if:

  • 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

You may not qualify if:

  • Preoperative atrial fibrillation
  • Preoperative critical state
  • Emergent/salvage surgery
  • Heart transplant surgery
  • Left ventricular assist device implantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29116972DERIVED

MeSH Terms

Interventions

Cardiac Surgical Procedures

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Head of Department

Study Record Dates

First Submitted

May 11, 2016

First Posted

May 12, 2016

Study Start

June 1, 2016

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

November 23, 2016

Record last verified: 2016-06