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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03563378
Date of registration: 21/05/2018
Prospective Registration: Yes
Primary sponsor: RenJi Hospital
Public title: Effects of Intraoperative Normal Saline vs Lactated Ringer on Outcomes in Pediatric Liver Transplantation
Scientific title: Effects of Intraoperative Normal Saline vs Lactated Ringer on Outcomes in Pediatric Liver Transplantation: A Double-blind Randomized Trial
Date of first enrolment: July 28, 2018
Target sample size: 200
Recruitment status: Unknown status
URL:  https://clinicaltrials.gov/show/NCT03563378
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
China
Contacts
Name:     diansan su, Dr.
Address: 
Telephone: +862168383702
Email: diansansu@yahoo.com
Affiliation: 
Name:     qi lu, Dr.
Address: 
Telephone:
Email:
Affiliation:  Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
Name:     diansan su, Dr.
Address: 
Telephone: +862168383702
Email: diansansu@yahoo.com
Affiliation: 
Key inclusion & 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



Age minimum: 3 Months
Age maximum: 6 Years
Gender: All
Health Condition(s) or Problem(s) studied
Biliary Atresia Intrahepatic Syndromic Form
Intervention(s)
Drug: Lactated Ringer
Drug: Normal saline
Primary Outcome(s)
Change in lactate level of the lactated ringer group compared to the normal saline group [Time Frame: up to 3 days after surgery]
Secondary Outcome(s)
Length of mechanical ventilation [Time Frame: up to 30 days after surgery]
30 day mortality [Time Frame: up to 30 days after surgery]
ICU stay [Time Frame: up to 30 days after surgery]
Secondary ID(s)
2017-162
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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