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临床试验/NCT03780686
NCT03780686已完成不适用

The Effect of Adding Dopamine Infusion to Noradrenaline Infusion Combined With Restrictive Hydration on Renal Function and Tissue Perfusion During Open Abdominal Surgeries

Ain Shams University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年4月9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
120
试验地点
1
主要终点
Changes in renal function test

研究概览

简要总结

This study was designed to assess the effect of adding dopamine infusion in addition to restrictive hydration combined with noradrenaline infusion on intraoperative serum lactate levels as an indicator for tissue hypo perfusion and renal function in comparison to restrictive hydration combined with noradrenaline infusion only and standard hydration during open abdominal surgeries.

详细描述

One hundred and twenty patients were randomly assigned into three groups (dopamine norepinephrine group, restrictive hydration group and liberal hydration group) undergoing open abdominal procedures (radical cystectomy and hemi colectomy). In Restrictive group (n=40): Ringer's solution was infused at a rate of 1 ml.kg.h-1 until the basic part of the surgery (tumor resection) is completed to be followed by 3 ml.kg.h-1 of Ringer's solution until the end of surgery. Noradrenaline infusion (0.07mcg.kg.min-1) was combined with fluids until the end of surgery. In Liberal group (n=40): the conventional fluid replacement was introduced according to maintenance, deficit for the first 3 hours (hours fasting x body weight) and 3rd space loss (estimated between 8-10 ml.kg.h-1).

The outcome to be assessed was serial measurements of serum lactate intraoperatively and immediate postoperatively as an index of tissue perfusion, in addition to blood pressure, heart rate and oxygen saturation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Care Provider)

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

  • All patients with American Society of Anesthesiologists (ASA) physical status I or II
  • Age range from 18-80 years scheduled to either radical cystectomy or hemicolectomy were contained in the study.

排除标准

  • Patients with coagulopathies,
  • Hepatic dysfunction (prothrombin ratio <50%),
  • Renal dysfunction,
  • Congestive heart failure (New York Heart Association scores ≥3),
  • Contraindications for epidural analgesia (e.g. patient refusal, local infection or coagulopathy), and peripheral vascular disease.

研究组 & 干预措施

Dopamine and norepinephrine infusion

Active Comparator

Infusion doppamine (2-5mcg/kg/min) and norepinephrine (3mcg/kg/h) with restricted fluid

干预措施: Norepinephrine, dopamine (Drug)

Norepinephrine

Active Comparator

Infusion norepinephrine (3mcg/kg/h) with restricted fluid.

干预措施: Norepinephrine, dopamine (Drug)

结局指标

主要结局

Changes in renal function test

时间窗: Before induction of anesthesia and up to 12 hours after.

Measuring creatinine level

Changes in serum lactate level

时间窗: Before induction of anesthesia and up to 12 hours after.

Serum lactate level in mmol/l

次要结局

未报告次要终点

研究者

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

Ayman Anis Metry

Assistant professor

Ain Shams University

研究点 (1)

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