Effects of Intraoperative Normal Saline vs Lactated Ringer on Outcomes in Pediatric Liver Transplantation

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Intraoperative Normal Saline vs Lactated Ringer on Outcomes in Pediatric Liver Transplantation: A Double-blind Randomized Trial

Conditions
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Biliary Atresia Intrahepatic Syndromic Form

Intervention / Treatment
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* Drug: Lactated Ringer
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Criteria Inclusion Criteria: Pediatric patients between the age of 3 month and 6 years Scheduled for living donor liver transplantation Exclusion Criteria: Re-transplantation Combined liver and kidney transplantation Congenital heart disease Refused to participate the study

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactated ringers solution<br>Participants in this group will receive Lactated Ringer's solution during the intraoperative period. | Drug: Lactated Ringer<br>* Patients will be administered Lactated Ringer's solution for intraoperative fluid management.<br>|
| Experimental: Normal saline solution<br>Participants in this group will receive Normal saline solution during the intraoperative period. | Drug: Normal saline<br>* Patients will be administered normal saline for intraoperative fluid management.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of mechanical ventilation | Length of mechanical ventilation in ICU measured in hours | up to 30 days after surgery | 
| ICU stay | Days spend in ICU within 30 days | up to 30 days after surgery | 
| 30 day mortality | Patient mortality during the first 30 days after surgery | up to 30 days after surgery |