Effects of Intraoperative Normal Saline vs Lactated Ringer on Outcomes in Pediatric Liver Transplantation
1 other identifier
interventional
200
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2018
CompletedFirst Posted
Study publicly available on registry
June 20, 2018
CompletedStudy Start
First participant enrolled
July 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2020
CompletedJune 20, 2018
June 1, 2018
1.8 years
May 21, 2018
June 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
up to 3 days after surgery
Secondary Outcomes (3)
Length of mechanical ventilation
up to 30 days after surgery
ICU stay
up to 30 days after surgery
30 day mortality
up to 30 days after surgery
Study Arms (2)
Lactated ringers solution
EXPERIMENTALParticipants in this group will receive Lactated Ringer's solution during the intraoperative period.
Normal saline solution
EXPERIMENTALParticipants in this group will receive Normal saline solution during the intraoperative period.
Interventions
Patients will be administered Lactated Ringer's solution for intraoperative fluid management.
Patients will be administered normal saline for intraoperative fluid management.
Eligibility Criteria
You may qualify if:
- Pediatric patients between the age of 3 month and 6 years
- Scheduled for living donor liver transplantation
You may not qualify if:
- Re-transplantation
- Combined liver and kidney transplantation
- Congenital heart disease
- Refused to participate the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
Study Sites (1)
Renji Hospital
Shanghai, Shanghai Municipality, 200127, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
qi lu, Dr.
Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2018
First Posted
June 20, 2018
Study Start
July 28, 2018
Primary Completion
May 27, 2020
Study Completion
May 27, 2020
Last Updated
June 20, 2018
Record last verified: 2018-06