Back to resultsEffects of Intraoperative Normal Saline vs Lactated Ringer on Outcomes in Pediatric Liver Transplantation
Primary Purpose
Biliary Atresia Intrahepatic Syndromic Form
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lactated Ringer
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Atresia Intrahepatic Syndromic Form
Eligibility Criteria
Criteria
Inclusion Criteria:
- Pediatric patients between the age of 3 month and 6 years
- Scheduled for living donor liver transplantation
Exclusion Criteria:
- Re-transplantation
- Combined liver and kidney transplantation
- Congenital heart disease
- Refused to participate the study
Sites / Locations
- Renji HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Lactated ringers solution
Normal saline solution
Arm Description
Participants in this group will receive Lactated Ringer's solution during the intraoperative period.
Participants in this group will receive Normal saline solution during the intraoperative period.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Length of mechanical ventilation
Length of mechanical ventilation in ICU measured in hours
ICU stay
Days spend in ICU within 30 days
30 day mortality
Patient mortality during the first 30 days after surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03563378
Brief Title
Effects of Intraoperative Normal Saline vs Lactated Ringer on Outcomes in Pediatric Liver Transplantation
Official Title
Effects of Intraoperative Normal Saline vs Lactated Ringer on Outcomes in Pediatric Liver Transplantation: A Double-blind Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 28, 2018 (Anticipated)
Primary Completion Date
May 27, 2020 (Anticipated)
Study Completion Date
May 27, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Atresia Intrahepatic Syndromic Form
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lactated ringers solution
Arm Type
Experimental
Arm Description
Participants in this group will receive Lactated Ringer's solution during the intraoperative period.
Arm Title
Normal saline solution
Arm Type
Experimental
Arm Description
Participants in this group will receive Normal saline solution during the intraoperative period.
Intervention Type
Drug
Intervention Name(s)
Lactated Ringer
Intervention Description
Patients will be administered Lactated Ringer's solution for intraoperative fluid management.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Patients will be administered normal saline for intraoperative fluid management.
Primary Outcome Measure Information:
Title
Change in lactate level of the lactated ringer group compared to the normal saline group
Description
Baseline serum lactate will be measured after randomization and again after surgery, then every 24 hours for 72 hours
Time Frame
up to 3 days after surgery
Secondary Outcome Measure Information:
Title
Length of mechanical ventilation
Description
Length of mechanical ventilation in ICU measured in hours
Time Frame
up to 30 days after surgery
Title
ICU stay
Description
Days spend in ICU within 30 days
Time Frame
up to 30 days after surgery
Title
30 day mortality
Description
Patient mortality during the first 30 days after surgery
Time Frame
up to 30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Criteria
Inclusion Criteria:
Pediatric patients between the age of 3 month and 6 years
Scheduled for living donor liver transplantation
Exclusion Criteria:
Re-transplantation
Combined liver and kidney transplantation
Congenital heart disease
Refused to participate the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
diansan su, Dr.
Phone
+862168383702
Email
diansansu@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
qi lu, Dr.
Organizational Affiliation
Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
diansan su, Dr.
Phone
+862168383702
Email
diansansu@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effects of Intraoperative Normal Saline vs Lactated Ringer on Outcomes in Pediatric Liver Transplantation
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