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临床试验/NCT03146143
NCT03146143已完成不适用

Effect of Ultra Filtration on Extravascular Lung Water Assessed by Lung Ultrasound in Pediatric Cardiac Surgery

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Lung ultrasound score

研究概览

简要总结

study will assess the effect the ultrafiltration after pediatric congenital heart surgery on cardiopulmonary bypass. patients will be divided into two groups. first group will receive ultrafiltration and the second group will be control group without filtration.

we will assess extravascular lung water by lung ultrasound, arterial oxygen tension and duration of ventilation.

详细描述

The anesthesiologist will interview the guardians; examine the patients, checking all routine investigations include: CBC(complete blood count), coagulation profile, liver function tests, renal function tests, blood grouping, chest X-ray, recent echocardiography and angiography if available.

Children will be received Midazolam 0.3 mg/kg IM (intramuscular) and Atropine 0.02 mg/kg IM 10 min as pre-medication before induction.

Induction of anesthesia will be established using fentanyl, 1-5µg/kg, ketamine 1-2 g/kg. Atracurium 0.5mg/kg will be administered to facilitate endotracheal intubation and repeated intraoperative as required to maintain muscle relaxation. Anesthesia will be maintained using sevoflurane 0.3%-2 % in oxygen-air mixture (1:1 ratio). A central venous line will be inserted and arterial line for invasive blood pressure monitoring. The use of inotropes will be guided by the patient's hemodynamics after surgical repair. Dobutamine 5-10 µg/Kg/min, Tridil 1-4 µg/Kg/ min, Adrenaline 0.05µg/kg/min or Milrinone 0.5µg/kg/min will be used according to pathophysiology and Intraoperative state of patient.

In all patients, a median sternotomy will be performed. CPB will be initiated after full heparinization in a dose of 300-400 I.U to achieve a n ACT( activated clotting time) of 450 sec or 3 times baseline reading followed by the standard aorta-bicaval cannulation. A membrane oxygenator (Mini-max Plus; Medtronic Inc., Anaheim, CA) and a non-pulsatile roller pump (model 10.10.00; Stôckert Instruments; Munich, Germany) will be used. Venting of the left heart will be performed with a left atrial vent inserted through a small incision at the interatrial septum. Priming fluids consist of lactated Ringer's solution supplemented with heparin. Fresh whole blood was added to the priming solution in appropriate amounts to achieve a hematocrit of 20% to 22% during CPB ( cardiopulmonary bypass). Moderate hypothermia (26°C to 28°C) will be used during CPB.

After cardiac repair the patient will be weaned from CPB. protamine will be given 3-4 mg/kg to reverse heparin. The control group will not subjected to ultrafiltration and the ultrafiltration group will be subjected to conventional ultrafiltration guided by hematocrit level 28%.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
1 Month 至 4 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatrics undergoing congenital heart surgery
  • Age 1 months to 4 years
  • ASA II and III
  • Weight more than 3 kg

排除标准

  • pre-operative mechanical ventilation
  • Pre-operative inotropic support.
  • Patients with lung disease (asthma, bronchiectasis)
  • Preoperative renal impairment (cr > 1.5mg/dl)

研究组 & 干预措施

ultrafiltration group

Experimental

ultrafiltration after cardiopulmonary bypass in congenital cardiac surgery

干预措施: ultrafiltration (Procedure)

non ultrafiltration control group

No Intervention

no ultrafiltration will be applied in this group

结局指标

主要结局

Lung ultrasound score

时间窗: at the end of surgery

assess extravascular lung water in the form of B lines in lung ultrasound

次要结局

  • ultrafiltration volume(at the end of surgery)
  • lung ultrasound score(baseline 5 minutes after induction of anesthesia)
  • duration of ventilation(up to 2 weeks)
  • creatinine(baseline, day 1 postoperative in icu. day 2 postoperative in icu)
  • P/F ratio(baseline 5 minutes after induction of anesthesia and at the end of surgery)
  • urea(baseline, day 1 postoperative in icu. day 2 postoperative in icu)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Elayashy Mohamed Ahmed Hassan

clinical professor

Kasr El Aini Hospital

研究点 (1)

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