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

NCT07547020 | Not Yet Recruiting

• 1 other identifier: Terapia intensiva el cruce
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Liver Transplantation; Shock; Hemodynamic Instability

Outcome Measures

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.

  Within the first 24 hours after ICU admission

Secondary Outcomes (5)

• Hemodynamic Profile Classification Based on Cardiovascular Coupling

  Within the first 24 hours after ICU admission

• Degree of Hemodynamic Coherence

  Within the first 24 hours after ICU admission

• 30-Day Mortality

  30 days

• Organ Dysfunction within the first 24 hours after ICU admission

  Within the first 24 hours after ICU admission

• Duration of Mechanical Ventilation and Successful Liberation from Mechanical Ventilation

  Up to 30 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

Sponsors & Collaborators

• Hospital El Cruce: lead

Study Sites (1)

Hospital de Alta Complejidad en Red El Cruce

San Juan Bautista, Buenos Aires, 1853, Argentina

Location

Related Publications (6)

• 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.

  PMID: 30896570 BACKGROUND

• 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.

  PMID: 39527481 BACKGROUND

• 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.

  PMID: 37834818 BACKGROUND

• 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.

  PMID: 12454326 BACKGROUND

• 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.

  PMID: 36204192 BACKGROUND

• 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.

  PMID: 33534523 BACKGROUND

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nestor Pistillo, MD

CONTACT

+541134367989; nestor.pistillo@hospitalelcruce.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Intensive Care Medicine

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 23, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)