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

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

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.

Study Overview

• Status: Unknown
• Conditions: Biliary Atresia
• Intervention / Treatment: Drug: Bicarbonate Ringer's solution; Drug: Other Crystalloid

• Study Type: Observational
• Enrollment (Anticipated): 110

Contacts and Locations

• Study Contact: Name: Jiexiong Feng, prof.; Phone Number: 86- 18607187276; Email: wangpeipeggy@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study Population was diagnosed with biliary atresia, who need Intravenous infusion.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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 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	Drug: Other Crystalloid; According to the choices of the patients' immediate family members, patients will be divided into other clinical used crystalloid. no Intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Principal Investigator: Jiexiong Feng, Tongji Hospital of Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 1, 2020
• Primary Completion (ANTICIPATED): August 1, 2021
• Study Completion (ANTICIPATED): October 1, 2021

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (ACTUAL): August 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Biliary Atresia; Bicarbonate Ringer's solution; Perioperative fluid management
• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Biliary Tract Diseases; Bile Duct Diseases; Digestive System Abnormalities; Biliary Atresia
• Other Study ID Numbers: TJH-MCTBR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No