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

Biliary Atresia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04506021
• Other study ID #: TJH-MCTBR
• Status: Not yet recruiting
• Start date: August 2020
• Est. completion date: October 2021

Study information

• Verified date: August 2020
• Source: Tongji Hospital
• Contact: Jiexiong Feng, prof.
• Phone: 18607187276
• Email: wangpeipeggy[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: October 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 90 Days

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Atresia

Intervention

Drug:
• Bicarbonate Ringer's solution
According to the choices of the patients' immediate family members, patients will be divided into Bicarbonate Ringer's Solution. no Intervention.
• Other Crystalloid
According to the choices of the patients' immediate family members, patients will be divided into other clinical used crystalloid. no Intervention.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial blood gas changes	Compared with the baseline, the patient's base excess and pH changes at the operation 1h, operation 2h, and the end of the operation.	1 day
Primary	Intraoperative dosage of sodium bicarbonate injection	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	1 day
Primary	Chlorine concentration	We collected the concentration of chloride ion in the patient's blood and urine during the baseline, the operation and three days after operation	3 days