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

Not Applicable

• Conditions: Biliary Atresia Intrahepatic Syndromic Form
• Interventions: Drug: Lactated Ringer; Drug: Normal saline

• Registration Number: NCT03563378
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-21
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-19
• Last Update Submitted: 2018-06-19
• Study First Posted: 2018-06-20
• Last Update Posted: 2018-06-20
• Study Start: 2018-07-28
• Primary Completion: 2020-05-27
• Study Completion: 2020-05-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactated ringers solution	Lactated Ringer	Participants in this group will receive Lactated Ringer's solution during the intraoperative period.
Normal saline solution	Normal saline	Participants in this group will receive Normal saline solution during the intraoperative period.

Primary Outcome Measures

Name	Time	Method
Change in lactate level of the lactated ringer group compared to the normal saline group	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

Secondary Outcome Measures

Name	Time	Method
Length of mechanical ventilation	up to 30 days after surgery	Length of mechanical ventilation in ICU measured in hours
30 day mortality	up to 30 days after surgery	Patient mortality during the first 30 days after surgery
ICU stay	up to 30 days after surgery	Days spend in ICU within 30 days

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China