跳至主要内容
临床试验/NCT03448848
NCT03448848已完成不适用

Role of Branched-chain Amino Acids Infusion as Adjunct Therapy Post Liver Surgery for Patients in Intensive Care Unit

National Hepatology & Tropical Medicine Research Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年3月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
effect on liver function tests

研究概览

简要总结

The purpose of this study is to evaluate the impact of intravenous BCAAs infusion as adjunct therapy post liver surgery in intensive care unit (ICU).

详细描述

Patients will be enrolled in the study&randomly assigned in a 1:1 manner to receive either intravenous (IV) BCAAs in a dose of 0.5-1gm/Kg/day for at least 48hours up to maximum 5 days immediately post-operative or placebo (sterile normal saline in a volume equal to the study drug).

All demographic data will be obtained including the patients' age, sex, weight,associated co-morbidities (diabetes mellitus & hypertension), the presence of chronic liver disease (CLD), Child-Pugh score, Sequential Organ Failure Assessment (SOFA), the type of liver surgery, & nutritional status according to nutritional risk screening 2002 (NRS 2002); well-nourished if NRS 2002 < 3 while malnourished if NRS 2002 ≥ 3 prior BCAAs infusion.

Vital signs including the heart rate, mean arterial pressure (MAP), central venous pressure (CVP), arterial oxygen saturation (SaO2), insulin requirements, urine volume & fluid balance will be recorded on admission (day 0), then will be followed up and recorded at regular intervals during treatment on 1, 3, 5 &7days.

Laboratory investigations including the complete blood profile (white blood cells, band%, lymphocytes), prothrombin time (PT), liver enzymes; Aspartate aminotransferase (AST), Alanine aminotransferase (ALT),serum bilirubin, serum albumin, C-reactive protein (CRP)& kidney functions will be recorded at randomization as a baseline (day 0)& will be assessed on day 0,1, 3, 5 & 7 of the study. Thirty-day survival & infectious morbidity will be followed by phone calls to the patient or one of his/her first-degree relatives.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The subjects are adults aged between 18& 75years who are admitted to the ICU of National Hepatology & Tropical Medicine Research Institute (NHTMRI) post liver surgery e.g. hepatocellular carcinoma, liver hemangioma, hydatid resection, segmentectomy, partial hepatectomy as in donor for living donated liver transplant.

排除标准

  • if pregnant.
  • hemodynamic instability requiring circulatory support.
  • need for dose of BCAAs > 1gm/Kg/day or < 0.5 gm/Kg/day.
  • severe malnutrition; body mass index (BMI < 16).

研究组 & 干预措施

study

Experimental

干预措施: BCAA preparation Intravenous infusion (Drug)

control

Placebo Comparator

干预措施: sterile normal saline (Drug)

结局指标

主要结局

effect on liver function tests

时间窗: within one week post surgery

improvement of prothrombin time

Child-Pugh score post-surgery.

时间窗: within one week post surgery

Improvement with BCAA infusion

SOFA score post-surgery

时间窗: within one week post surgery

improvement with BCAA infusion

次要结局

  • 30-day infectious morbidity Infectious morbidity(30 days post surgery)
  • non infectious morbidity(30 days)
  • ICU stay. length of ICU stay, length of hospital stay & 28day mortality. length of ICU stay, length of hospital stay & 28day mortality. length of ICU stay, length of hospital stay & 28day mortality.(within two weeks post surgery)
  • Hospital stay. length of ICU stay, length of hospital stay & 28day mortality. length of ICU stay, length of hospital stay & 28day mortality. length of ICU stay, length of hospital stay & 28day mortality.(within two weeks post surgery)
  • mortality(28 day)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

ICU

Consultant of Intensive care medicine, Ph D

National Hepatology & Tropical Medicine Research Institute

研究点 (1)

Loading locations...

相似试验