Biliary Atresia Intrahepatic Syndromic FormNCT03563378
Effects of Intraoperative Normal Saline vs Lactated Ringer on Outcomes in Pediatric Liver Transplantation
A study testing Lactated Ringer and Normal saline in people with Biliary Atresia Intrahepatic Syndromic Form, run by RenJi Hospital at 1 site in China.
Trial summary
Lactated Ringer(LR) has been extensively used to maintain and replace intravascular volume in a variety of anesthetic procedures. However, the utility of LR in pediatric with hepatic failure undergoing liver transplantation is unclear, because addition of exogenous lactate may increase lactate concentration. Read more about this study
- Who is it for?
- Ages 3 months to 6 years
- Conditions the study is for
- Biliary Atresia Intrahepatic Syndromic Form
- What is being tested?
- Lactated Ringer and Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2018to 27 May 2020
- Phase
- Interventional
- 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 3 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients between the age of 3 month and 6 years
- Scheduled for living donor liver transplantation
Who cannot join
- Re-transplantation
- Combined liver and kidney transplantation
- Congenital heart disease
- Refused to participate the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200127
diansan su, Dr., +862168383702, diansansu@yahoo.com
About this study
Official title: Effects of Intraoperative Normal Saline vs Lactated Ringer on Outcomes in Pediatric Liver Transplantation: A Double-blind Randomized Trial
Lactated Ringer(LR) has been extensively used to maintain and replace intravascular volume in a variety of anesthetic procedures. However, the utility of LR in pediatric with hepatic failure undergoing liver transplantation is unclear, because addition of exogenous lactate may increase lactate concentration. In addition,large amounts of normal saline(NS) which does not contain lactate can induce a hyperchloremic metabolic acidosis and have been asociated with adverse effects on kidney injury, coagulation, and death. Accordingly, the investigators performed a double-blinded randomized trial comparing the effects of intraoperative NS or LR on outcomes in pediatric receiving Liver transplantation.
- Being tested
- Lactated Ringer, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactated RingerDrug
Patients will be administered Lactated Ringer's solution for intraoperative fluid management.
Normal salineDrug
Patients will be administered normal saline for intraoperative fluid management.
| Study group | Role | What they receive |
|---|---|---|
| Lactated ringers solution | Experimental | Participants in this group will receive Lactated Ringer's solution during the intraoperative period. Receives: Drug: Lactated Ringer |
| Normal saline solution | Experimental | Participants in this group will receive Normal saline solution during the intraoperative period. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lactate level of the lactated ringer group compared to the normal saline group
Baseline serum lactate will be measured after randomization and again after surgery, then every 24 hours for 72 hours
Measured: up to 3 days after surgery
Secondary outcomes (3)
Length of mechanical ventilation
Length of mechanical ventilation in ICU measured in hours
Measured: up to 30 days after surgery
ICU stay
Days spend in ICU within 30 days
Measured: up to 30 days after surgery
30 day mortality
Patient mortality during the first 30 days after surgery
Measured: up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start28 Jul 2018 (estimated)
- Primary completion27 May 2020 (estimated)
- Study completion27 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Atresia Intrahepatic Syndromic FormStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- qi lu, Dr., Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563378
- Sponsor's protocol ID
- 2017-162
- Status last verified
- Jun 2018
- First submitted
- 21 May 2018
- Last updated
- 20 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intraoperative Normal Saline vs Lactated Ringer on Outcomes in Pediatric Liver Transplantation: A Double-blind Randomized Trial
- ClinicalTrials.gov ID
- NCT03563378
- Acronym / sponsor ID
- 2017-162
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 28 Jul 2018 (estimated)
- Primary completion
- 27 May 2020 (estimated)
- Study completion
- 27 May 2020 (estimated)
- First posted
- 20 Jun 2018 (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.
Lactated Ringer(LR) has been extensively used to maintain and replace intravascular volume in a variety of anesthetic procedures. However, the utility of LR in pediatric with hepatic failure undergoing liver transplantation is unclear, because addition of exogenous lactate may increase lactate concentration. In addition,large amounts of normal saline(NS) which does not contain lactate can induce a hyperchloremic metabolic acidosis and have been asociated with adverse effects on kidney injury, coagulation, and death. Accordingly, the investigators performed a double-blinded randomized trial comparing the effects of intraoperative NS or LR on outcomes in pediatric receiving Liver transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactated ringers solution | Experimental | Drug: Lactated RingerParticipants in this group will receive Lactated Ringer's solution during the intraoperative period. |
| Normal saline solution | Experimental | Drug: Normal salineParticipants in this group will receive Normal saline solution during the intraoperative period. |
Who may qualify
- Ages
- 3 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric patients between the age of 3 month and 6 years
- Scheduled for living donor liver transplantation
Key exclusion criteria (4 listed)
- Re-transplantation
- Combined liver and kidney transplantation
- Congenital heart disease
- Refused to participate the study
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 |
|---|---|---|
| Lactated RingerPatients will be administered Lactated Ringer's solution for intraoperative fluid management. | Drug | Lactated ringers solution |
| Normal salinePatients will be administered normal saline for intraoperative fluid management. | Drug | Normal saline solution |
Primary outcome
Change in lactate level of the lactated ringer group compared to the normal saline group
Time frame: up to 3 days after surgery
Baseline serum lactate will be measured after randomization and again after surgery, then every 24 hours for 72 hours
3 secondary outcomes
Length of mechanical ventilation
Time frame: up to 30 days after surgery
ICU stay
Time frame: up to 30 days after surgery
30 day mortality
Time frame: up to 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Individual participant dataSharing planned: Undecided
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.
qi lu, Dr. principal investigator
Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactated Ringer and Normal saline in people with Biliary Atresia Intrahepatic Syndromic Form, run by RenJi Hospital at 1 site in China.
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 2 inclusion and 4 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 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 diansan su, Dr. (+862168383702, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lactate level of the lactated ringer group compared to the normal saline group (time frame: up to 3 days after surgery). 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 20 Jun 2018.