A Multicenter Real World Study on Clinical Efficacy of Sodium Bicarbonate Ringer's Solution in Children With Biliary Atresia
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Tongji Hospital
- Enrollment
- 110
- Primary Endpoint
- Chlorine concentration
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 90 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients diagnosed with biliary atresia before surgery.
- •age less than 90 days.
- •American Society of Anesthesiologists score of 1~2.
Exclusion Criteria
- •patients with severe allergies.
- •patients with severe deformities or lesions.
- •other situations not suitable for enrollment judged by researchers.
Arms & Interventions
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
Intervention: Bicarbonate Ringer's solution (Drug)
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
Intervention: Other Crystalloid (Drug)
Outcomes
Primary Outcomes
Chlorine concentration
Time Frame: 3 days
We collected the concentration of chloride ion in the patient's blood and urine during the baseline, the operation and three days after operation
Intraoperative dosage of sodium bicarbonate injection
Time Frame: 1 day
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
Arterial blood gas changes
Time Frame: 1 day
Compared with the baseline, the patient's base excess and pH changes at the operation 1h, operation 2h, and the end of the operation.
Secondary Outcomes
No secondary outcomes reported
Investigators
J.X. Feng
prof.
Tongji Hospital