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Liver TransplantationCOHERENCE-LTNCT07547020

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

An observational study of Liver Transplantation and Shock, run by Hospital El Cruce at 1 site in Argentina.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
60 participants
Where
1 siteArgentina
Study dates
1 May 2026to 1 Sep 2027
How long will I take part?
30 Days
Phase
Observational
Are there results?
Not yet: the study is under way

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

Who may be able to join

None listed.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Argentina1 site
  • Hospital de Alta Complejidad en Red El Cruce

    San Juan Bautista, Buenos Aires, 1853

Other trials in Argentina

About this study

Official title: Hemodynamic Profiles and Macro-Microcirculatory Coherence in Liver Transplantation: An Integrative Approach to the Immediate Postoperative Period

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.

Read more

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.

Read the detailed description

Hemodynamic instability during liver transplantation is a complex and multifactorial condition resulting from the interaction between the pathophysiological alterations of advanced cirrhosis, the hemodynamic impact of the surgical procedure, and perioperative complications. Patients with end-stage liver disease typically exhibit a hyperdynamic circulatory state characterized by reduced systemic vascular resistance, increased cardiac output, and impaired vascular responsiveness. These baseline alterations are further challenged during transplantation by factors such as hemorrhage, fluid shifts, vena cava clamping, reperfusion syndrome, myocardial dysfunction, vasoplegia, graft-related factors, and infectious complications.

From a physiological perspective, the cardiovascular system can be understood as a network responsible for the generation, transmission, and utilization of energy to ensure adequate tissue perfusion. Hemodynamic instability may therefore be interpreted as a disruption in one or more of these components. However, conventional hemodynamic monitoring strategies are primarily based on macrocirculatory variables, such as mean arterial pressure and cardiac output, which may not adequately reflect microcirculatory perfusion or cellular oxygen utilization.

This dissociation between global hemodynamic variables and tissue perfusion has been described as a loss of hemodynamic coherence. In this context, patients may present with apparently adequate systemic hemodynamic parameters while still developing tissue hypoxia and organ dysfunction. This limitation highlights the need for a more integrative approach to hemodynamic assessment.

The present study is based on the evaluation of four key hemodynamic interfaces that represent fundamental components of cardiovascular function: (1) left ventricle-arterial system coupling, which reflects the efficiency of energy transfer from the heart to the arterial system; (2) macro-microcirculatory coherence, which describes the relationship between systemic hemodynamics and tissue-level perfusion; (3) venous return-right atrial interaction, which determines the capacity of the system to sustain cardiac output; and (4) right ventricle-pulmonary circulation coupling, which reflects the interaction between the right heart and pulmonary vascular load.

The disruption or decoupling of these interfaces may lead to different patterns of hemodynamic inefficiency, contributing to the heterogeneity observed in critically ill patients undergoing liver transplantation. Identifying these patterns may provide a more precise understanding of the underlying mechanisms of instability and allow for a more individualized therapeutic approach.

The primary objective of this study is to characterize and categorize hemodynamic profiles in adult patients during the immediate postoperative period following liver transplantation. The study also aims to determine the incidence of tissue hypoxia within the first 24 hours after surgery and to evaluate its association with clinical outcomes, including 30-day mortality and organ dysfunction.

This is a prospective, observational study conducted in the intensive care unit of a high-complexity hospital. Adult patients admitted after liver transplantation who develop hemodynamic instability, defined as the requirement for vasoactive agents to maintain a mean arterial pressure of at least 65 mmHg, will be included. Patients with conditions that significantly interfere with hemodynamic assessment or limit short-term prognosis will be excluded.

During the first 24 hours after ICU admission, patients will undergo multimodal hemodynamic monitoring. Data collection will include macrocirculatory variables (such as arterial pressure and cardiac output), echocardiographic assessment of ventricular function, indicators of venous congestion, variables related to pulmonary circulation, and markers of tissue perfusion. Tissue hypoxia will be defined using a combination of clinical and biochemical criteria, including elevated lactate levels, prolonged capillary refill time, reduced urine output, and alterations in oxygenation parameters.

Based on these measurements, the degree of coupling between the different cardiovascular interfaces will be assessed, and patients will be classified into hemodynamic profiles according to the predominant pathophysiological mechanism. These profiles will be analyzed in relation to the occurrence of tissue hypoxia and clinical outcomes.

Statistical analysis will be performed to evaluate differences between hemodynamic profiles, temporal trends during the first 24 hours, and their association with outcomes at 30 days. Continuous variables will be described using appropriate measures of central tendency and dispersion, while categorical variables will be expressed as proportions. Comparative and exploratory analyses will be conducted as appropriate.

This study aims to provide a comprehensive physiological framework for understanding hemodynamic instability in liver transplantation. By integrating macrocirculatory and microcirculatory perspectives, this approach may contribute to the development of more precise monitoring strategies and individualized therapeutic interventions in critically ill patients.

Medical subject headings
Shock

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within the first 24 hours after ICU admission

Secondary outcomes (5)
  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.

    Measured: 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.

    Measured: Within the first 24 hours after ICU admission

  3. 30-Day Mortality

    All-cause mortality within 30 days following liver transplantation.

    Measured: 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.

    Measured: Within the first 24 hours after ICU admission

  5. Duration of Mechanical Ventilation and Successful Liberation from Mechanical Ventilation

    Duration of invasive mechanical ventilation measured in days from initiation to successful liberation. Successful liberation is defined as sustained spontaneous breathing without the need for invasive mechanical ventilation for at least 48 consecutive hours.

    Measured: Up to 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

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
Prospective
Enrolment
60 participants (estimated)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT07547020
Sponsor's protocol ID
Terapia intensiva el cruce
Acronym
COHERENCE-LT
Status last verified
Apr 2026
First submitted
14 Apr 2026
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
Individual data sharing
No

Publications

  • He HW, Long Y, Liu DW, Ince C. Resuscitation incoherence and dynamic circulation-perfusion coupling in circulatory shock. Chin Med J (Engl). 2019 May 20;132(10):1218-1227. doi: 10.1097/CM9.0000000000000221.

    PubMed 30896570
  • Huang L, Huang Q, Ma W, Yang H. UNDERSTANDING HEMODYNAMIC INCOHERENCE: MECHANISMS, PHENOTYPES, AND IMPLICATIONS FOR TREATMENT. Shock. 2025 Mar 1;63(3):342-350. doi: 10.1097/SHK.0000000000002507. Epub 2024 Nov 8.

    PubMed 39527481
  • Agostini C, Buccianti S, Risaliti M, Fortuna L, Tirloni L, Tucci R, Bartolini I, Grazi GL. Complications in Post-Liver Transplant Patients. J Clin Med. 2023 Sep 24;12(19):6173. doi: 10.3390/jcm12196173.

    PubMed 37834818
  • Newby DE, Hayes PC. Hyperdynamic circulation in liver cirrhosis: not peripheral vasodilatation but 'splanchnic steal'. QJM. 2002 Dec;95(12):827-30. doi: 10.1093/qjmed/95.12.827. No abstract available.

    PubMed 12454326
  • Wang L, Bui CM, Hofer I, Gabel E, Wray C, Xia VW. Intraoperative Hypotension and 30-D Mortality After Liver Transplantation. Transplant Direct. 2022 Sep 15;8(10):e1380. doi: 10.1097/TXD.0000000000001380. eCollection 2022 Oct.

    PubMed 36204192
  • Bezinover D, Mukhtar A, Wagener G, Wray C, Blasi A, Kronish K, Zerillo J, Tomescu D, Pustavoitau A, Gitman M, Singh A, Saner FH. Hemodynamic Instability During Liver Transplantation in Patients With End-stage Liver Disease: A Consensus Document from ILTS, LICAGE, and SATA. Transplantation. 2021 Oct 1;105(10):2184-2200. doi: 10.1097/TP.0000000000003642.

    PubMed 33534523

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Transplantation and Shock, run by Hospital El Cruce at 1 site in Argentina.

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 0 inclusion and 1 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: opening soon, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nestor Pistillo, MD (+541134367989, nestor.pistillo@hospitalelcruce.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Tissue Hypoxia in the First 24 Hours After Liver Transplantation (time frame: Within the first 24 hours after ICU admission). 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 NCT07547020, which also lists 6 linked publications.

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 1 May 2026.

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