Restrictive Fluid Management In Liver Transplantation (REFIL)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Low splanchnic blood volume restrictive fluid management strategy, Phlebotomy, Optimized cardiac output liberal fluid management strategy.
- Кому может быть актуально
- Состояния в реестре: Liver Transplantation (LT), End-stage Liver Disease (ESLD). Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effects of an Intraoperative Low-splanchnic Blood Volume Restrictive Fluid Management Strategy Compared to a Cardiac Output Optimized Liberal Fluid Management Strategy on Postoperative Outcomes in Liver Transplantation: A Multicenter Randomized Controlled Trial (REFIL-2)
Обзор
The goal of the REFIL-2 study is to evaluate the effectiveness of a low splanchnic blood volume restrictive fluid management strategy (a strategy that involves limiting fluid administration and prioritizing the use of medications that raise blood pressure during surgery, combined with phlebotomy) in improving patients' recovery after surgery. The study compares the low splanchnic blood volume restrictive fluid management strategy to an optimized cardiac-output liberal fluid management strategy (which involves administering more fluids to raise blood pressure with less reliance on medications). Outcomes important to patients will be measured. This study (REFIL-2) had a vanguard phase (internal pilot) that included 138 patients (NCT05647733). The patients included in the vanguard pilot phase were not compared between groups but only analyzed descriptively using aggregated data. Only feasibility metrics were compared (see NCT05647733). These 138 patients were thus rolled into the REFIL-2 trial and included in the final sample size reported herein.
Подробное описание
People with advanced liver disease have poor blood circulation, and too much blood accumulates in the abdomen (a condition known as high intra-abdominal blood volume). However, liver transplantation (LT) is a complex surgery during which the patient can lose a significant amount of blood and blood pressure can fluctuate widely. Therefore, restricting fluids and using medications to raise blood pressure is a strategy that could reduce blood loss and potentially also certain complications after surgery. Furthermore, phlebotomy appears to reduce intra-abdominal blood volume, blood loss, drops in blood pressure, and the need for red blood cell transfusions, potentially improving recovery after surgery. This study therefore aims to determine the best way to manage fluids during a liver transplantation by comparing these two care strategies. Another goal of the study is to measure the cost-effectiveness of the proposed intervention.
Hypothesis: An intraoperative low splanchnic blood volume restrictive fluid management strategy is superior to an optimized cardiac-output liberal fluid management strategy in reducing postoperative severe complications after liver transplantation
Design: Multicenter blinded parallel arm randomized controlled trial
Study population: Adult patients undergoing a liver transplantation for end-stage liver disease (ESLD)
All participants will be followed during their index hospitalization up to post-transplantation Day 30 (whichever comes first), and for 12 months post-transplantation to assess some clinical outcomes, quality of life (QoL), and survival (being alive beyond the index hospitalization).
Participation in this study lasts 12 months.
The results of this study will help determine whether or not to recommend a low splanchnic blood volume restrictive fluid management strategy for people who undergo a liver transplantation.
This study is conducted in two phases: a pilot phase, which demonstrated feasibility across Canada, followed by the current larger-scale phase (REFIL-2).
Вмешательства
- Процедура Low splanchnic blood volume restrictive fluid management strategy
Hemodynamic goal-directed restrictive fluid management strategy - Процедура Phlebotomy
Blood drawn in a blood donation bag prior to dissection and transfused back after graft reperfusion - Процедура Optimized cardiac output liberal fluid management strategy
Permissive hemodynamic goal-directed fluid management strategy that optimizes cardiac output throughout surgery
Первичные конечные точки
- Number of participants with at least one severe complication [Срок оценки: Up to hospital discharge (from surgery to hospital discharge) or 30 days, whichever comes first]
Вторичные конечные точки (12)
- Number of participants who were transfused at least one unit of red blood cells (RBC) during the perioperative period of surgery [Срок оценки: During surgery (from entrance in the operating to exit of the operating room) and up to 48 hours after surgery (from exit of the operating room to 48 hours after exit of the operating room)]
- Number of participants who were transfused at least one unit of red blood cells (RBC) during surgery [Срок оценки: Intraoperative (from entrance in the operating room to exit of the operating room)]
- Intraoperative blood loss [Срок оценки: Intraoperative (from entrance in the operating room to exit of the operating room)]
- 7-day quality of recovery [Срок оценки: One time point: 7 days after surgery (transplantation)]
- Number of participants with a 7-day graft dysfunction [Срок оценки: One time point: 7 days after surgery (transplantation)]
- Number of participants with a 7-day acute kidney injury (AKI) [Срок оценки: Over 7 days after surgery (criteria met at any day from surgery to day 7 after surgery)]
- Number of participants who were transfused at least one unit of red blood cells (RBC) up to hospital discharge [Срок оценки: From surgery to hospital discharge (from entrance in the operating room to hospital discharge) or 30 days, whichever comes first]
- Number of participants who were transfused at least one unit of any labile blood product up to hospital discharge [Срок оценки: From surgery to hospital discharge (from entrance in the operating room to hospital discharge) or 30 days, whichever comes first]
- Number of participants with at least one postoperative hemorrhagic complication up to hospital discharge [Срок оценки: Up to hospital discharge (from surgery to hospital discharge) or 30 days, whichever comes first]
- Number of participants with postoperative acute kidney injury (AKI) up to hospital discharge [Срок оценки: Up to hospital discharge (from surgery to hospital discharge) or 30 days, whichever comes first]
- Number of participants requiring renal replacement therapy (RRT) up to hospital discharge [Срок оценки: Up to hospital discharge (from surgery to hospital discharge) or 30 days, whichever comes first]
- Number of participants with at least one postoperative graft complication up to hospital discharge [Срок оценки: Up to hospital discharge (from surgery to hospital discharge) or 30 days, whichever comes first]
Критерии участия
Критерии включения
- Adult ≥ 18 years old
- Undergoing liver transplantation (LT)
- End-stage liver disease (ESLD) (with or without hepatocellular carcinoma) as the indication for transplantation.
Критерии исключения
- Undergoing LT for an indication other than ESLD (e.g., acute liver failure, primary liver cancer without ESLD, retransplantation, amyloid neuropathy, polycystic liver disease, or any other indication not associated with ESLD)
- Undergoing combined solid organ transplantations
- Any of the following conditions:
- severe chronic renal failure (GFR < 15 ml/minute/1.73 m2 \[CKD-EPI equation\] or already on renal replacement therapy (RRT))
- severe anemia (hemoglobin level < 80 g/L)
- hemodynamic instability (norepinephrine equivalent > 10 ug/min)
- Physician refusal to enroll the patient.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Канада · 4 центра
- Vancouver General Hospital (VGH) — Vancouver
- London Health Sciences Centre (LHSC) — London
- Centre hospitalier de l'Université de Montréal (CHUM) — Montreal
- McGill University Health Centre (MUHC) — Montreal
Публикации
- Carrier FM, Chasse M, Wang HT, Aslanian P, Iorio S, Bilodeau M, Turgeon AF. Restrictive fluid management strategies and outcomes in liver transplantation: a systematic review. Can J Anaesth. 2020 Jan;67(1):109-127. doi: 10.1007/s12630-019-01480-y. Epub 2019 Sep 25. PMID 31556006
- Thacker JK, Mountford WK, Ernst FR, Krukas MR, Mythen MM. Perioperative Fluid Utilization Variability and Association With Outcomes: Considerations for Enhanced Recovery Efforts in Sample US Surgical Populations. Ann Surg. 2016 Mar;263(3):502-10. doi: 10.1097/SLA.0000000000001402. PMID 26565138
- Shin CH, Long DR, McLean D, Grabitz SD, Ladha K, Timm FP, Thevathasan T, Pieretti A, Ferrone C, Hoeft A, Scheeren TWL, Thompson BT, Kurth T, Eikermann M. Effects of Intraoperative Fluid Management on Postoperative Outcomes: A Hospital Registry Study. Ann Surg. 2018 Jun;267(6):1084-1092. doi: 10.1097/SLA.0000000000002220. PMID 28288059
- Parikh A, Washburn KW, Matsuoka L, Pandit U, Kim JE, Almeda J, Mora-Esteves C, Halff G, Genyk Y, Holland B, Wilson DJ, Sher L, Koneru B. A multicenter study of 30 days complications after deceased donor liver transplantation in the model for end-stage liver disease score era. Liver Transpl. 2015 Sep;21(9):1160-8. doi: 10.1002/lt.24181. PMID 25991395
Идентификаторы
NCT: NCT07695363 · 22.206