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

NCT ID: NCT04506021

Last Updated: 2020-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-31

Study Completion Date

2021-10-31

Brief Summary

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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

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Conditions

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Biliary Atresia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Bicarbonate Ringer's solution

Intervention Type DRUG

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

Other Crystalloid

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Other Crystalloid

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

Intervention Type DRUG

Eligibility Criteria

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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.
Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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J.X. Feng

prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiexiong Feng

Role: PRINCIPAL_INVESTIGATOR

Tongji hospital of huazhong university of science and technology

Central Contacts

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Jiexiong Feng, prof.

Role: CONTACT

18607187276 ext. 86-

Other Identifiers

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TJH-MCTBR

Identifier Type: -

Identifier Source: org_study_id

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