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临床试验/NCT04506021
NCT04506021Unknown不适用

A Multicenter Real World Study on Clinical Efficacy of Sodium Bicarbonate Ringer's Solution in Children With Biliary Atresia

Tongji Hospital0 个研究点目标入组 110 人开始时间: 2020年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
110
主要终点
Chlorine concentration

研究概览

简要总结

In most babies with biliary atresia (BA) bile ducts on the inside and outside of the liver are affected eventually leading to a complete blockage of bile flow from the liver. This in turn causes scarring (fibrosis) in the liver. The surgery called the Kasai procedure and eventually, a liver transplant could treat biliary atresia. However, children with BA have poor liver function, poor renal reserve, and poor ability to regulate water and electrolytes. Therefore, A reasonable and effective perioperative fluid management is more significant. Considering the high chlorine of saline, the liver burden of Lactated Ringer's solution and Acetated Ringer's solution, the Bicarbonate Ringer's solution which composition is similar to plasma, could be the best choice for perioperative fluid management of BA children. Therefore, we hypothesize that compared with other crystalloids, Bicarbonate Ringer's solution is a better choice to maintain water, electrolyte and acid-base balance in BA children.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 90 Days(Child)
性别
All
接受健康志愿者

入选标准

  • patients diagnosed with biliary atresia before surgery.
  • age less than 90 days.
  • American Society of Anesthesiologists score of 1~2.

排除标准

  • patients with severe allergies.
  • patients with severe deformities or lesions.
  • other situations not suitable for enrollment judged by researchers.

研究组 & 干预措施

Bicarbonate Ringer's Solution

According to the choices of the patients' immediate family members, patients will be divided into Bicarbonate Ringer's Solution.

drug dosage form: Solution, Intravenous infusion. the drug dosage frequency and duration were no intervention

干预措施: Bicarbonate Ringer's solution (Drug)

Other Crystalloid

According to the choices of patients' immediate family members, patients will be divided into Other Crystalloid.

drug dosage form: Solution, Intravenous infusion. the drug dosage frequency and duration were no intervention

干预措施: Other Crystalloid (Drug)

结局指标

主要结局

Chlorine concentration

时间窗: 3 days

We collected the concentration of chloride ion in the patient's blood and urine during the baseline, the operation and three days after operation

Intraoperative dosage of sodium bicarbonate injection

时间窗: 1 day

Patients with acidosis during the operation needs to be corrected with sodium bicarbonate injection. We collect the amount of sodium bicarbonate injection used to correct metabolic acidosis during the operation

Arterial blood gas changes

时间窗: 1 day

Compared with the baseline, the patient's base excess and pH changes at the operation 1h, operation 2h, and the end of the operation.

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

J.X. Feng

prof.

Tongji Hospital

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