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

Biliary Atresia Intrahepatic Syndromic Form Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03563378
• Other study ID #: 2017-162
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2018
• Est. completion date: May 27, 2020

Study information

• Verified date: June 2018
• Source: RenJi Hospital
• Contact: diansan su, Dr.
• Phone: +862168383702
• Email: diansansu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 27, 2020
• Est. primary completion date: May 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Biliary Atresia
• Biliary Atresia Intrahepatic Syndromic Form

Intervention

Drug:
• Lactated Ringer
Patients will be administered Lactated Ringer's solution for intraoperative fluid management.
• Normal saline
Patients will be administered normal saline for intraoperative fluid management.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

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