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

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.

Study Overview

• Status: Unknown
• Conditions: Biliary Atresia Intrahepatic Syndromic Form
• Intervention / Treatment: Drug: Lactated Ringer; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Renji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Criteria

Inclusion Criteria:

1. Pediatric patients between the age of 3 month and 6 years
2. Scheduled for living donor liver transplantation

Exclusion Criteria:

1. Re-transplantation
2. Combined liver and kidney transplantation
3. Congenital heart disease
4. Refused to participate the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Principal Investigator: qi lu, Dr., Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Anticipated): July 28, 2018
• Primary Completion (Anticipated): May 27, 2020
• Study Completion (Anticipated): May 27, 2020

Study Registration Dates

• First Submitted: May 21, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 20, 2018

Study Record Updates

• Last Update Posted (Actual): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Biliary Tract Diseases; Bile Duct Diseases; Digestive System Abnormalities; Biliary Atresia
• Other Study ID Numbers: 2017-162

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No