Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

Effect of Discarding Initial Reperfusion Blood on Hemodynamics, Liver Function, and 30-Day Outcomes in Liver Transplantation

keskiviikko 3. kesäkuuta 2026 päivittänyt: Joel Avancini Rocha Filho, University of Sao Paulo General Hospital

Assessment of the Impact of Discarding the Initial Reperfusion Blood on Early Liver Function, Cardiovascular and Metabolic Changes and on 30-Day Liver and Renal Outcomes. A Prospective Randomized Trial in Liver Transplantation

Hepatic reperfusion during liver transplantation remains a critical phase associated with significant hemodynamic and systemic disturbances, despite advances in surgical and anesthetic management. This phase is characterized by the release of acidotic, hypothermic, and hyperkalemic blood containing metabolic byproducts and inflammatory mediators resulting from ischemia-reperfusion injury.

Clinically, reperfusion is associated with hemodynamic instability, including reductions in cardiac output and arterial pressure, as well as cardiac dysfunction and arrhythmias, often requiring pharmacologic support. These alterations may affect not only immediate intraoperative stability but also short- and long-term outcomes for both the patient and the graft.

The abrupt restoration of blood flow to the transplanted liver leads to the systemic release of accumulated metabolites, reactive oxygen species, and inflammatory mediators, contributing to a systemic inflammatory response that may impact distant organs, including the kidneys and heart.

Several revascularization strategies have been investigated to mitigate reperfusion-related injury: initial reperfusion via the portal vein, initial reperfusion through the hepatic artery, and simultaneous reperfusion through the portal vein and hepatic artery.

A less frequently used and insufficiently studied strategy, not routinely or systematically implemented, involves diverting the initial reperfusion blood from the graft to the surgical field, followed by the restoration of hepatic blood outflow to the systemic circulation.

This study hypothesizes that discarding the initial reperfusion blood via the infrahepatic vena cava will attenuate early hemodynamic, metabolic, and inflammatory changes and reduce postoperative complications compared to conventional reperfusion techniques.

Tutkimuksen yleiskatsaus

Tila

Ei vielä rekrytointia

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

Hepatic reperfusion during liver transplantation remains a critical phase associated with significant hemodynamic and systemic disturbances, despite advances in surgical and anesthetic management. This phase is characterized by the release of acidotic, hypothermic, and hyperkalemic blood containing metabolic byproducts and inflammatory mediators resulting from ischemia-reperfusion injury.

Clinically, reperfusion is associated with hemodynamic instability, including reductions in cardiac output and arterial pressure, as well as cardiac dysfunction and arrhythmias, often requiring pharmacologic support. These alterations may compromise immediate intraoperative stability and have been associated with adverse short- and long-term outcomes for both the recipient and the graft.

The abrupt restoration of blood flow to the transplanted liver results in the systemic release of accumulated metabolites, reactive oxygen species, and inflammatory mediators, triggering a systemic inflammatory response that may extend beyond the liver and affect distant organs, including the kidneys and heart.

Several revascularization strategies have been investigated to mitigate reperfusion-related injury, including portal vein, hepatic artery, and simultaneous reperfusion approaches. However, none have consistently demonstrated a clear benefit in reducing ischemia-reperfusion injury or improving clinical outcomes. An alternative and less explored strategy involves diverting and discarding the initial reperfusion blood from the graft before restoring venous outflow to the systemic circulation.

Patients listed for liver transplantation at the study center will be systematically screened for eligibility. Written informed consent will be obtained from all eligible participants prior to enrollment, in accordance with institutional ethical standards.

This study is a prospective randomized clinical trial designed to evaluate whether discarding the initial reperfusion blood via the infrahepatic vena cava attenuates early hemodynamic, metabolic, and inflammatory disturbances and improves postoperative outcomes compared with conventional reperfusion techniques.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

132

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Tutki yhteystietojen varmuuskopiointi

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

Inclusion Criteria:

  • Adults aged 18 years or older
  • Candidates for liver transplantation at Hospital das Clínicas, University of São Paulo Medical School (HCFMUSP)
  • Able to provide written informed consent

Exclusion Criteria:

  • Inability to provide informed consent
  • Previous liver surgery
  • Fulminant hepatitis
  • Specific liver diseases associated with severe electrolyte disturbances
  • End-stage renal disease requiring dialysis
  • Combined organ transplantation
  • Living donor liver transplantation
  • Liver retransplantation
  • Highly sensitized patients with limited availability of blood products
  • Hematologic diseases
  • Portal vein thrombosis involving more than 50% of the lumen
  • Portopulmonary hypertension (mean pulmonary artery pressure > 20 mmHg), diagnosed preoperatively or intraoperatively

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Reperfusion Blood Discard
Liver transplantation with discarding of the initial 180 mL of reperfusion blood via the infrahepatic vena cava prior to restoration of hepatic blood outflow to the systemic circulation
Menettely: Reperfusion Blood Discard
Discarding of the initial 180 mL of reperfusion blood from the graft via the infrahepatic vena cava during liver transplantation prior to restoration of hepatic venous outflow to systemic circulation.
Active Comparator: Conventional Reperfusion
Standard liver transplantation without discarding the initial reperfusion blood.
Menettely: Standard Liver Transplantation
Conventional liver transplantation without discarding the initial reperfusion blood.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Peak alanine aminotransferase (ALT)
Aikaikkuna: Within 72 hours after transplantation
Peak serum ALT level (U/L) as a biomarker of early graft injury following liver transplantation.
Within 72 hours after transplantation

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Arterial Pressure
Aikaikkuna: Intraoperative, during reperfussion, 30 minutes after reperfusion, and postoperative day 1.
Monitoring arterial pressure (systolic, diastolic e medium) Unit of Measure: mmHg.
Intraoperative, during reperfussion, 30 minutes after reperfusion, and postoperative day 1.
Cardiac Rhythm
Aikaikkuna: Intraoperative, during reperfussion, 30 minutes after reperfusion, and postoperative day 1
Cardiac rhythm monitoring with electrocardiography in ECG lead 2 and V5
Intraoperative, during reperfussion, 30 minutes after reperfusion, and postoperative day 1
Cardiac Output
Aikaikkuna: Intraoperative, during reperfussion, 30 minutes after reperfusion, and postoperative day 1.
Monitoring continuous cardiac output. Unit of Measure: L/min.
Intraoperative, during reperfussion, 30 minutes after reperfusion, and postoperative day 1.
Arterial serum potassium levels
Aikaikkuna: Intraoperative and daily from postoperative day 1 up to day 7.
Perioperative changes in arterial potassium levels (Unit of measure: mEq/L).
Intraoperative and daily from postoperative day 1 up to day 7.
Blood coagulation thromboelastometry
Aikaikkuna: Intraoperative (at the start of surgery, 5 minutes after reperfusion, and at the end of surgery).
Assessment of intraoperative coagulation changes using rotational thromboelastometry (ROTEM), including EXTEM and FIBTEM parameters, and activated clotting time (ACT).
Intraoperative (at the start of surgery, 5 minutes after reperfusion, and at the end of surgery).
International normalized ratio (INR)
Aikaikkuna: Daily up to 72 hours after transplantation.
Assessment of graft function using international normalized ratio (INR).
Daily up to 72 hours after transplantation.
Aspartate aminotransferase levels (AST)
Aikaikkuna: Daily up to 7 days and weekly up to 30 days after transplantation.
Assessment of graft injury using serum levels of AST (Unit of measure: U/L).
Daily up to 7 days and weekly up to 30 days after transplantation.
Serum Tumor Necrosis Factor-alpha (TNF-α)
Aikaikkuna: At the start of surgery, end of surgery, postoperative day 1, and postoperative day 3.
Serum levels of inflammatory mediator TNF-α (Unit of measure: pg/mL).
At the start of surgery, end of surgery, postoperative day 1, and postoperative day 3.
Serum B-type natriuretic peptide (BNP)
Aikaikkuna: At the start of surgery, 30 minutes after reperfusion and postoperative day 1.
Assessment of BNP levels as a marker of cardiac hemodynamic stress. Unit of Measure: pg/mL.
At the start of surgery, 30 minutes after reperfusion and postoperative day 1.
Serum creatinine levels
Aikaikkuna: Up to 30 days after transplantation.
Assessment of serum creatinine levels to evaluate renal function (Unit of measure: mg/dL),
Up to 30 days after transplantation.
Postoperative complications
Aikaikkuna: Within 30 days after transplantation.
Complications graded according to the Clavien-Dindo classification.
Within 30 days after transplantation.
ICU length of stay
Aikaikkuna: Up to 30 days after transplantation.
Days of length of stay in the intensive care unit.
Up to 30 days after transplantation.
Hospital length of stay
Aikaikkuna: Up to 30 days after transplantation.
Total hospital length of stay in days.
Up to 30 days after transplantation.
Arterial serum sodium levels
Aikaikkuna: Intraoperative and daily from postoperative day 1 up to day 7.
Perioperative changes in arterial serum sodium levels (Unit of measure: mEq/L).
Intraoperative and daily from postoperative day 1 up to day 7.
Arterial serum lactate levels
Aikaikkuna: Intraoperative and daily from postoperative day 1 up to day 7.
Perioperative changes in arterial serum lactate levels (Unit of measure mg/dL),
Intraoperative and daily from postoperative day 1 up to day 7.
Arterial serum calcium levels
Aikaikkuna: Intraoperative and daily from postoperative day 1 up to day 7.
Perioperative changes in arterial serum calcium levels (Unit of measure mg/dL),
Intraoperative and daily from postoperative day 1 up to day 7.
Serum glucose levels
Aikaikkuna: Intraoperative and daily from postoperative day 1 up to day 7.
Perioperative changes in serum glucose levels (Unit of measure: mg/dL).
Intraoperative and daily from postoperative day 1 up to day 7.
Arterial serum pH
Aikaikkuna: Intraoperative and daily from postoperative day 1 up to day 7.
Perioperative changes in arterial pH units.
Intraoperative and daily from postoperative day 1 up to day 7.
Arterial serum bicarbonate
Aikaikkuna: Intraoperative and daily from postoperative day 1 up to day 7.
Perioperative changes in arterial serum bicarbonate (Unit of measure mmol/L)
Intraoperative and daily from postoperative day 1 up to day 7.
Factor V activity levels
Aikaikkuna: Daily up to 72 hours after transplantation .
Assessment of graft function using Factor V activity levels measure as percentage.
Daily up to 72 hours after transplantation .
Alkaline phosphatase levels
Aikaikkuna: Daily up to 7 days and weekly up to 30 days after transplantation.
Assessement of graft function using alkaline phosphatase levels (Unit of measure: U/L),
Daily up to 7 days and weekly up to 30 days after transplantation.
Gamma-glutamyl transferase levels
Aikaikkuna: Daily up to 7 days and weekly up to 30 days after transplantation.
Assessment of liver function using serum levels of gamma-glutamyl transferase up to 7 days and weekly up to 30 days after transplantation (Unit of measure: U/L).
Daily up to 7 days and weekly up to 30 days after transplantation.
Serum ammonia levels
Aikaikkuna: Daily up to 7 days and weekly up to 30 days after transplantation.
Assessment of serum ammonia levels to evaluate liver function.(Unit of measure: mcmol/L).
Daily up to 7 days and weekly up to 30 days after transplantation.
Serum urea levels
Aikaikkuna: Up to 30 days after transplantation.
Assessment of serum urea levels to evaluate renal function (Unit of measure: mg/dl),
Up to 30 days after transplantation.
Urine output
Aikaikkuna: Up to 30 days after transplantation.
Assessment of renal function measured by daily urine output.
Up to 30 days after transplantation.
Need for renal replacement therapy
Aikaikkuna: Up to 30 days after transplantation.
Need for renal replacement therapy (hemodialysis or continuous renal replacement therapy).
Up to 30 days after transplantation.
Serum Interleukin-6 (IL-6) levels
Aikaikkuna: At the start of surgery, end of surgery, postoperative day 1, and postoperative day 3.
Serum levels of inflammatory mediator IL-6 (Unit of measure: pg/mL),
At the start of surgery, end of surgery, postoperative day 1, and postoperative day 3.
Serum Tumor Necrosis Factor-alpha (TNF-α) levels
Aikaikkuna: At the start of surgery, end of surgery, postoperative day 1, and postoperative day 3.
Serum levels of inflammatory mediator TNF-α levels. (Unit of measure: pg/mL)
At the start of surgery, end of surgery, postoperative day 1, and postoperative day 3.
Serum Interleukin-17 (IL-17) levels
Aikaikkuna: At the start of surgery, end of surgery, postoperative day 1, and postoperative day 3.
Serum levels of inflammatory mediator IL-17 (Unit of measure: pg/mL).
At the start of surgery, end of surgery, postoperative day 1, and postoperative day 3.

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

University of Sao Paulo General Hospital

Tutkijat

  • Päätutkija: Joel Avancini Rocha Filho, MD, PhD, Hospital das Clínicas, University of São Paulo Medical School
  • Opintojohtaja: Estela Regina Ramos Figueira, MD, PhD, Hospital das Clínicas, University of São Paulo Medical School
  • Opintojohtaja: Maria Jose Carvalho Carmona, MD, PhD, Hospital das Clínicas, University of São Paulo Medical School
  • Opintojohtaja: Wellington Andraus, MD, PhD, Hospital das Clínicas, University of São Paulo Medical School
  • Opintojohtaja: Rui Carlos Detsch Junior, MD, Hospital das Clínicas, University of São Paulo Medical School
  • Opintojohtaja: Luciana Bertocco Paiva Haddad, MD, PhD, Hospital das Clínicas, University of São Paulo Medical School

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Arvioitu)

Keskiviikko 1. heinäkuuta 2026

Ensisijainen valmistuminen (Arvioitu)

Tiistai 1. helmikuuta 2028

Opintojen valmistuminen (Arvioitu)

Tiistai 1. helmikuuta 2028

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 15. huhtikuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Keskiviikko 3. kesäkuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Maanantai 8. kesäkuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Maanantai 8. kesäkuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 3. kesäkuuta 2026

Viimeksi vahvistettu

Keskiviikko 1. huhtikuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 92854125.8.0000.0068
  • 2025/09932-0 (Muu apuraha/rahoitusnumero: São Paulo Research Foundation (FAPESP))

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

EI

IPD-suunnitelman kuvaus

Individual participant data will not be shared due to institutional and privacy considerations.

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Tilaa