Ventriculo-arterial Coupling in Cirrhotics

Cirrhosis Clinical Trial

— VACCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03948659
• Other study ID #: CRC_GHN_2019_004
• Status: Completed
• Start date: August 30, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: May 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis

Intervention

Procedure:
• Arterio ventricular coupling
We analyse ventriculo arterial coupling (VAC) among cirrhotic patients admitted in intensive care unit, with non-invasive echography method

Locations

Country	Name	City	State
France	Hadrien Pambet	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.