Low Cardiac Output Syndrome After Adult Cardiac SurgeryNCT02771080
Peak Systolic Global Longitudinal Strain and Low Cardiac Output Syndrome After Cardiac Surgery
An observational study of Low Cardiac Output Syndrome After Adult Cardiac Surgery, run by University of Liege.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Cardiac Output Syndrome After Adult Cardiac Surgery
- What is being tested?
- Cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 275 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing on-pump elective or urgence cardiac surgery
Who may be able to join
- 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
Who cannot join
- Preoperative atrial fibrillation
- Preoperative critical state
- Emergent/salvage surgery
- Heart transplant surgery
- Left ventricular assist device implantation
About this study
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.
- Being tested
- Cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative low cardiac output syndrome
Need for pharmacological inotropic support during 24 hours or more post-operatively
Measured: 30 days
Secondary outcomes (6)
Length of intensive care unit stay
Measured: 30 days
Length of hospital stay
Measured: 30 days
30-day or in hospital mortality
Measured: 30 days
duration of post-operative mechanical ventilation
Measured: 30 days
post-operative acute kidney injury
Measured: 30 days
Need for readmission to the intensive care
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Cardiac Output Syndrome After Adult Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean François Brichant, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771080
- Sponsor's protocol ID
- CHULgstrain
- Status last verified
- Jun 2016
- First submitted
- 11 May 2016
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29116972
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peak Systolic Global Longitudinal Strain and Low Cardiac Output Syndrome After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02771080
- Acronym / sponsor ID
- CHULgstrain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing on-pump elective or urgence cardiac surgery
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- Preoperative atrial fibrillation
- Preoperative critical state
- Emergent/salvage surgery
- Heart transplant surgery
- Left ventricular assist device implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac surgery | Procedure or surgery | – |
Primary outcome
Post-operative low cardiac output syndrome
Time frame: 30 days
Need for pharmacological inotropic support during 24 hours or more post-operatively
6 secondary outcomes
Length of intensive care unit stay
Time frame: 30 days
Length of hospital stay
Time frame: 30 days
30-day or in hospital mortality
Time frame: 30 days
duration of post-operative mechanical ventilation
Time frame: 30 days
post-operative acute kidney injury
Time frame: 30 days
Need for readmission to the intensive care
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
- Derived from this study: PubMed 29116972Amabili 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Cardiac Output Syndrome After Adult Cardiac Surgery, run by University of Liege.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative low cardiac output syndrome (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02771080, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2016.