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

• Conditions: Biliary Atresia
• Interventions: Drug: Bicarbonate Ringer's solution; Drug: Other Crystalloid

• Registration Number: NCT04506021
• Lead Sponsor: Tongji Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study Start: 2020-08
• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-07
• Last Update Submitted: 2020-08-07
• Study First Posted: 2020-08-10
• Last Update Posted: 2020-08-10
• Primary Completion: 2021-08
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bicarbonate Ringer's Solution	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
Other Crystalloid	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

Primary Outcome Measures

Name	Time	Method
Chlorine concentration	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	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	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.