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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03563378

Enrollment

200

Registered

2018-06-20

Start date

2018-07-28

Completion date

2020-05-27

Last updated

2018-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Atresia Intrahepatic Syndromic Form

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.

Interventions

DRUGLactated Ringer

Patients will be administered Lactated Ringer's solution for intraoperative fluid management.

DRUGNormal saline

Patients will be administered normal saline for intraoperative fluid management.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Months to 6 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

China

Contacts

Primary Contactdiansan su, Dr.

diansansu@yahoo.com+862168383702

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026