Goal-directed LCVP Based on HP in Laparoscopic Hepatectomy

Официальное название

The Application of Goal-directed Low Central Venous Pressure Based on Hypovolemic Phlebotomy in Laparoscopic Hepatectomy

Обзор

The goal of this clinical trial is to learn about goal-directed LCVP based on hypovolemic phlebotomy (HP) in laparoscopic hepatectomy. The main questions it aims to answer are: 1. The safety and feasibility of HP 2. To evaluate whether HP can reduce perioperative blood transfusion ratio Participants undergoing liver resection with HP was performed by the anesthesiologist. Blood was withdrawn approximately 30 min prior to the initiation of liver parenchymal transection from central venous. The aim was to maintain the CVP between 0 to 5 cmH2O. HP volume was 5-10 mL/kg of patient body weight, generally. Participants in control group undergoing liver resection without HP.

Вмешательства

• Процедура hypovolemic phlebotomy
  hypovolemic phlebotomy was performed after induction of anesthesia and before the star of parenchymal division, with a goal-directed low central venous pressure drop to 5mmHg.

Первичные конечные точки

• The proportion of allogeneic red blood cell products transfusion [Срок оценки: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.]

Вторичные конечные точки (12)

• The volume of Phlebotomy [Срок оценки: From the start of operation until the end of operation.]
• The volume of Intraoperative blood loss [Срок оценки: From the start of operation until the end of operation (during the operation).]
• The volume of Allogeneic transfusion (perioperative) [Срок оценки: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.]
• The volume of Allogeneic transfusion (postoperative) [Срок оценки: From the end of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.]
• The volume of Allogeneic transfusion (intraoperative) [Срок оценки: From the start of operation until the end of operation.]
• The volume of Fresh frozen plasm (FFP) transfusion [Срок оценки: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.]
• The volume of Platelets transfusion [Срок оценки: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.]
• The volume of Albumin transfusion [Срок оценки: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.]
• Perioperative lowest concentration of Hb [Срок оценки: From the start of operation until the date of discharge from hospital or date of death from any cause, whichever came first. assessed up to 12 months.]
• Pre-transection central venous pressure (CVP), (basic CVP) [Срок оценки: From the start of anesthesia induction until the star of operation.]
• Lowest central venous pressure (CVP) [Срок оценки: From the start of operation until the end of operation (during the operation).]
• time of pringle maneuver [Срок оценки: From the start of operation until the end of operation.]

Критерии участия

Критерии включения

• Clinical diagnosis of Hepatocellular Carcinoma
• Preference for laparoscopic hepatectomy and patient agreement

Критерии исключения

• Age <18 years
• Pregnancy
• Refusal of blood product transfusion
• Active cardiac conditions (unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease, history of congestive heart failure)
• History of significant cerebrovascular disease
• Restrictive or obstructive pulmonary disease
• Uncontrolled hypertension
• Renal dysfunction (glomerular filtration rate <60 mL/min),
• Hemoglobin <100 g/L
• Abnormal coagulation values (international normalized ratio >1.5 not on warfarin and/or platelet count <100 ×109/L)
• Evidence of hepatic metabolic disorder (bilirubin >35 mmol/L)
• Presence of active infection
• Preoperative autologous blood donation
• Patients were not allowed to receive erythropoietin at any time during the index hospitalization.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Nanjing Medical University — Нанкин

Идентификаторы

NCT: NCT05887661 · 2022-SR-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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