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Status unknownNCT04506021Updated Aug 10, 2020

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

An observational study in Biliary Atresia, sponsored by Tongji Hospital. Status unknown. Open to participants aged Up to 90 Days. Per ClinicalTrials.gov, last updated 2020-08-10.

Sponsored by Tongji Hospital · Observational

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
110
Ages
Up to 90 Days
Sex
All
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Study 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.

02

Conditions studied

  • Biliary Atresia

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Keywords

  • Biliary Atresia
  • Bicarbonate Ringer's solution
  • Perioperative fluid management
03

In context

Biliary Atresia

75 studies on the registry are indexed under Biliary Atresia; 25 are open to participants now.

This study's planned enrollment of 110 is below the median of 126 across 31 observational studies indexed under Biliary Atresia.

Browse Biliary Atresia studies →

Lead sponsor

Tongji Hospital is the lead sponsor of 373 studies on the registry; 204 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 90 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
110 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DrugBicarbonate Ringer's solution

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

  • DrugOther Crystalloid

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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

  2. 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

    Time frame: 1 day

  3. 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

    Time frame: 3 days

07

Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04506021
Lead sponsor
Tongji Hospital
Responsible party
J.X. Feng (prof., Tongji Hospital) — Principal investigator
First posted
Aug 10, 2020
Start date
Aug 2020 (estimated)
Primary completion
Aug 2021 (estimated)
Completion
Oct 2021 (estimated)
Last update
Aug 10, 2020

Study contacts

Jiexiong Feng, prof.
Contact
wangpeipeggy@126.com
18607187276 ext. 86-
Jiexiong Feng
principal investigator · Tongji hospital of huazhong university of science and technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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