Biliary AtresiaNCT04506021
A Real World Study on Clinical Efficacy of Bicarbonate Ringer's Solution in Biliary Atresia Children
An observational study of Biliary Atresia, run by Tongji Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 90 days
- Conditions the study is for
- Biliary Atresia
- What is being tested?
- Bicarbonate Ringer's solution and Other Crystalloid
- Type of treatment
- Injection or infusion
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Aug 2020to Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 90 days
- All sexes
- No healthy volunteers
- Child
Study population: Study Population was diagnosed with biliary atresia, who need Intravenous infusion.
Who may be able to join
- patients diagnosed with biliary atresia before surgery.
- age less than 90 days.
- American Society of Anesthesiologists score of 1~2.
Who cannot join
- patients with severe allergies.
- patients with severe deformities or lesions.
- other situations not suitable for enrollment judged by researchers.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Biliary Atresia
- Being tested
- Bicarbonate Ringer's solution, Other Crystalloid
- Keywords
- Biliary Atresia, Bicarbonate Ringer's solution, Perioperative fluid management
- Medical subject headings
- Biliary Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bicarbonate Ringer's solutionDrug
According to the choices of the patients' immediate family members, patients will be divided into Bicarbonate Ringer's Solution. no Intervention.
Other CrystalloidDrug
According to the choices of the patients' immediate family members, patients will be divided into other clinical used crystalloid. no Intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Other Crystalloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study startAug 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary AtresiaStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.X. Feng, Tongji Hospital
- Investigators
- Jiexiong Feng, Principal investigator, Tongji hospital of huazhong university of science and technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506021
- Sponsor's protocol ID
- TJH-MCTBR
- Status last verified
- Aug 2020
- First submitted
- 3 Aug 2020
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Real World Study on Clinical Efficacy of Sodium Bicarbonate Ringer's Solution in Children With Biliary Atresia
- ClinicalTrials.gov ID
- NCT04506021
- Acronym / sponsor ID
- TJH-MCTBR
- Conditions
- Biliary Atresia
- Keywords
- Biliary Atresia, Bicarbonate Ringer's solution, Perioperative fluid management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bicarbonate Ringer's Solution | – | Drug: Bicarbonate Ringer's solutionAccording 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 |
| Other Crystalloid | – | Drug: Other CrystalloidAccording 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 |
Who may qualify
- Ages
- Up to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Study Population was diagnosed with biliary atresia, who need Intravenous infusion.
Key inclusion criteria (3 listed)
- patients diagnosed with biliary atresia before surgery.
- age less than 90 days.
- American Society of Anesthesiologists score of 1~2.
Key exclusion criteria (3 listed)
- patients with severe allergies.
- patients with severe deformities or lesions.
- other situations not suitable for enrollment judged by researchers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bicarbonate Ringer's solutionAccording to the choices of the patients' immediate family members, patients will be divided into Bicarbonate Ringer's Solution. no Intervention. | Drug | Bicarbonate Ringer's Solution |
| Other CrystalloidAccording to the choices of the patients' immediate family members, patients will be divided into other clinical used crystalloid. no Intervention. | Drug | Other Crystalloid |
Primary outcome
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.
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiexiong Feng principal investigator
Tongji hospital of huazhong university of science and technology
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Atresia, run by Tongji Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiexiong Feng, prof. (18607187276 ext. 86-, wangpeipeggy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial blood gas changes (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2020.