Ventriculo-arterial Coupling in Cirrhotics (VACCI)

Non-invasive Assessment of Ventriculo Arterial Coupling Among Cirrhotics in Intensive Care Unit

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.

Study Overview

• Status: Completed
• Conditions: Cirrhosis
• Intervention / Treatment: Procedure: Arterio ventricular coupling

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hadrien Pambet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cirrhotic patients with acute decompensation admitted in intensive care unit and who received norepinephrine as hemodynamic therapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2018
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): May 14, 2019
• Last Update Submitted That Met QC Criteria: May 13, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: CRC_GHN_2019_004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No