Hemodynamic Profiles and Macro-Microcirculatory Coherence in Liver Transplantation: an Integrative Approach in the Immediate Postoperative Period

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital El Cruce

About this trial

Hemodynamic instability is a common and serious condition in patients undergoing liver transplantation and is associated with increased morbidity and mortality if not promptly recognized and treated. It results from multiple interacting factors, including blood loss, changes in vascular tone, cardiac dysfunction, and complications related to the surgical procedure.

Traditional monitoring strategies focus on global hemodynamic variables such as blood pressure and cardiac output. However, these parameters may not accurately reflect tissue perfusion or oxygen delivery at the microcirculatory level. As a result, patients may appear hemodynamically stable while still experiencing inadequate tissue oxygenation.

This study aims to evaluate hemodynamic instability using an integrative physiological approach based on the interaction between different components of the cardiovascular system. Specifically, the study will assess four key interfaces: the relationship between the heart and the arterial system, the coherence between macrocirculation and microcirculation, the interaction between venous return and the right atrium, and the coupling between the right ventricle and the pulmonary circulation.

The main objective is to identify distinct hemodynamic profiles in patients during the immediate postoperative period following liver transplantation. In addition, the study will evaluate the incidence of tissue hypoxia within the first 24 hours and its association with clinical outcomes, including 30-day evolution.

This is a prospective observational study conducted in adult patients admitted to the intensive care unit after liver transplantation who develop hemodynamic instability requiring vasoactive support. During the first 24 hours, multimodal hemodynamic monitoring will be performed, including assessment of cardiac function, vascular tone, venous congestion, pulmonary circulation, and markers of tissue perfusion such as lactate levels and capillary refill time.

By integrating these variables, patients will be classified into different hemodynamic profiles according to the predominant underlying mechanism. This approach aims to improve the understanding of cardiovascular dysfunction in this setting and to support more individualized and physiologically guided management strategies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Participants will be recruited from the intensive care unit of a high-complexity tertiary care hospital where liver transplantation is routinely performed

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Incidence of Tissue Hypoxia in the First 24 Hours After Liver Transplantation

Tissue hypoxia will be defined by the presence of at least one of the following criteria: elevated blood lactate levels, prolonged capillary refill time, reduced urine output, or impaired oxygenation parameters, reflecting inadequate tissue perfusion despite hemodynamic support.

Time frame
Within the first 24 hours after ICU admission

Secondary outcomes

1

Hemodynamic Profile Classification Based on Cardiovascular Coupling

Patients will be classified into distinct hemodynamic profiles according to the predominant mechanism of instability, based on the assessment of left ventricle-arterial coupling, macro-microcirculatory coherence, venous return-right atrial interaction, and right ventricle-pulmonary circulation coupling.

Time frame
Within the first 24 hours after ICU admission
2

Degree of Hemodynamic Coherence

Assessment of the relationship between macrocirculatory variables and markers of tissue perfusion to determine the presence of hemodynamic coherence or incoherence.

Time frame
Within the first 24 hours after ICU admission
3

30-Day Mortality

All-cause mortality within 30 days following liver transplantation.

Time frame
30 days
4

Organ Dysfunction within the first 24 hours after ICU admission

Presence of organ dysfunction (renal, cardiovascular, or respiratory) assessed according to standard clinical criteria.

Time frame
Within the first 24 hours after ICU admission

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: