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

NCT04506021 | Unknown

• 1 other identifier: TJH-MCTBR
• Study Type: observational
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Biliary Atresia

Keywords

Biliary Atresia; Bicarbonate Ringer's solution; Perioperative fluid management

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

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

Interventions

Bicarbonate Ringer's solution DRUG

According to the choices of the patients' immediate family members, patients will be divided into Bicarbonate Ringer's Solution. no Intervention.

Bicarbonate Ringer's Solution

Other Crystalloid DRUG

According to the choices of the patients' immediate family members, patients will be divided into other clinical used crystalloid. no Intervention.

Other Crystalloid

Eligibility Criteria

• Age: Up to 90 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Conditions

Biliary Atresia

Interventions

glutathione-bicarbonate-Ringer solution

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Digestive System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jiexiong Feng

  Tongji hospital of huazhong university of science and technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiexiong Feng, prof.

CONTACT

18607187276; wangpeipeggy@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 10, 2020
• Study Start: August 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: October 1, 2021
• Last Updated: August 10, 2020

Record last verified: 2020-08