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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Biliary Atresia Intrahepatic Syndromic Form

Treatments: Drug: Lactated Ringer; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03563378

2017-162

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 3 months to 6 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

200 participants in 2 patient groups

Lactated ringers solution

Experimental group

Description:

Participants in this group will receive Lactated Ringer's solution during the intraoperative period.

Treatment:

Drug: Lactated Ringer

Normal saline solution

Experimental group

Description:

Participants in this group will receive Normal saline solution during the intraoperative period.

Treatment:

Drug: Normal saline