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Ventriculo-arterial Coupling in Cirrhotics (VACCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948659
Recruitment Status : Completed
First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:

Cirrhotic in intensive care unit have a very specific haemodynamic status. Cardiovascular abnormalities in advanced liver cirrhosis are characterized by a hyperdynamic circulation featuring increased heart rate and high cardiac output, concomitant with decreased systemic vascular resistance. As liver cirrhosis progresses, cardiac dysfunction, known as cirrhotic cardiomyopathy, is associated with prognosis of these patients.

Specifically, diastolic dysfunction has been more emphasized for estimating clinical outcome in cirrhotic patients, whereas systolic dysfunction has limited prognostic implications in hepatorenal syndrome patients.

However, in most cirrhotic patients, cardiac dysfunction is latent and only manifests under stressful conditions because reduced ventricular contractility in these patients is masked by pronounced arterial vasodilation and increased arterial compliance. Therefore, a load-dependent index such as left ventricular ejection fraction is insensitive to detect systolic cardiac impairment in the resting state in cirrhotic patients. Hence, a more appropriate index is required to evaluate the integration of the ventricular and arterial systems in cirrhotic cardiovascular disorders.

Interaction between the left ventricle and the arterial system has been explained on the basis of end-systolic pressure-volume relation. Left ventricular end-systolic elastance (Ees), as quantified by the ratio of end-systolic pressure to end-systolic volume, is an index of the load-independent ventricular contractile state. Given this pressure-volume relationship, effective arterial elastance (Ea) can be calculated by the ratio of end-systolic pressure to stroke volume, indicating a net measure of arterial load. The ratio of these values (Ea/Ees), designated ventriculo-arterial coupling (VAC), represents the integrated interaction of the ventricular and arterial systems.

We can evaluate it with non-invasive echocardiographic method.

We analyse VAC among cirrhotic patients admitted in intensive care unit, with non-invasive echographic method thanks to records made from August 2018 to April 2019.

Hypothesis: VAC decrease from the baseline value when mean arterial pressure is improved.


Condition or disease Intervention/treatment
Cirrhosis Procedure: Arterio ventricular coupling

Study Design
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Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Non-invasive Assessment of Ventriculo Arterial Coupling Among Cirrhotics in Intensive Care Unit
Actual Study Start Date : August 30, 2018
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Cirrhotic patients in intensive care unit Procedure: Arterio ventricular coupling
We analyse ventriculo arterial coupling (VAC) among cirrhotic patients admitted in intensive care unit, with non-invasive echography method


Outcome Measures
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Primary Outcome Measures :
  1. Ventriculo arterial coupling [ Time Frame: Ventriculo arterial coupling is estimated at T0 (before norepinephrine initiation) and every 6 hours during the first 24 hours. ]
    The primary outcome is the non-invasive evaluation of ventriculo arterial coupling using a trans-thoracic echography


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cirrhotic patients with acute decompensation admitted in intensive care unit and who received norepinephrine as hemodynamic therapy
Criteria

Inclusion Criteria:

  • Liver cirrhotic patients (any cause, any level)
  • With acute decompensation
  • Admitted in intensive care unit in Croix Rousse Hospital, Lyon, France
  • Who receive NOREPINEPHRINE as hemodynamic therapy
  • Blood pressure monitoring thanks to an arterial line (radial, humeral or femoral)
  • Urinary catheter, suprapubic catheter or any comparable device to monitor urine output.
  • The patient did not object to take part of the study.

Exclusion Criteria:

  • Acute hemorrhage (Clinical definition or hemoglobin lower than 70g/L at admission)
  • Patient requiring kidney replacement therapy
  • Patient requiring invasive mechanical ventilation
  • Any pathology that makes non-invasive ventriculo arterial coupling assessment impossible (non-sinus rhythm, severe valvular disease)
  • Patient who objects to take part of the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948659


Locations
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France
Hadrien Pambet
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03948659    
Other Study ID Numbers: CRC_GHN_2019_004
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibrosis
Pathologic Processes