NCT05887661招募中不适用
The Application of Goal-directed Low Central Venous Pressure Based on Hypovolemic Phlebotomy in Laparoscopic Hepatectomy
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The proportion of allogeneic red blood cell products transfusion
研究概览
简要总结
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:
- The safety and feasibility of HP
- 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 Blood was withdrawn approximately 30 min prior to the initiation of liver parenchymal transection from central venous.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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Hepatocellular Carcinoma
- •Preference for laparoscopic hepatectomy and patient agreement
排除标准
- •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.
结局指标
主要结局
The proportion of allogeneic red blood cell products transfusion
时间窗: 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 primary end point of the study was the proportion of patients who required transfusion of allogeneic red blood cell products during laparoscopic hepatectomy or at any time during the hospitalization during the index admission.
次要结局
- number of pringle maneuver(From the start of operation until the end of operation.)
- The volume of Allogeneic transfusion (postoperative)(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 (perioperative)(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 Fresh frozen plasm (FFP) transfusion(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.)
- Number of Participants with postoperative complications (overall)(From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 1 months.)
- The volume of Phlebotomy(From the start of operation until the end of operation.)
- The volume of Intraoperative blood loss(From the start of operation until the end of operation (during the operation).)
- The volume of Allogeneic transfusion (intraoperative)(From the start of operation until the end of operation.)
- time of pringle maneuver(From the start of operation until the end of operation.)
- The proportion of laparoscopic hepatectomy converted to open liver resection(From the start of operation until the end of operation.)
- The volume of Albumin transfusion(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(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.)
- operating time(From the start of operation until the end of operation.)
- The volume of Platelets transfusion(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.)
- Pre-transection central venous pressure (CVP), (basic CVP)(From the start of anesthesia induction until the star of operation.)
- Lowest central venous pressure (CVP)(From the start of operation until the end of operation (during the operation).)
- Length of stay(From date of hospitalization until the date of discharge from hospital or date of death from any cause, whichever came first. assessed up to 12 months)
研究者
Shijiang Liu, MD
Clinical Professor
The First Affiliated Hospital with Nanjing Medical University
研究点 (1)
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