Effects of Intraoperative Normal Saline vs Lactated Ringer on Outcomes in Pediatric Liver Transplantation
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|ClinicalTrials.gov Identifier: NCT03563378|
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : June 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Biliary Atresia Intrahepatic Syndromic Form||Drug: Lactated Ringer Drug: Normal saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Effects of Intraoperative Normal Saline vs Lactated Ringer on Outcomes in Pediatric Liver Transplantation: A Double-blind Randomized Trial|
|Estimated Study Start Date :||July 28, 2018|
|Estimated Primary Completion Date :||May 27, 2020|
|Estimated Study Completion Date :||May 27, 2020|
Experimental: Lactated ringers solution
Participants in this group will receive Lactated Ringer's solution during the intraoperative period.
Drug: Lactated Ringer
Patients will be administered Lactated Ringer's solution for intraoperative fluid management.
Experimental: Normal saline solution
Participants in this group will receive Normal saline solution during the intraoperative period.
Drug: Normal saline
Patients will be administered normal saline for intraoperative fluid management.
- Change in lactate level of the lactated ringer group compared to the normal saline group [ Time Frame: 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
- Length of mechanical ventilation [ Time Frame: up to 30 days after surgery ]Length of mechanical ventilation in ICU measured in hours
- ICU stay [ Time Frame: up to 30 days after surgery ]Days spend in ICU within 30 days
- 30 day mortality [ Time Frame: up to 30 days after surgery ]Patient mortality during the first 30 days after surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563378
|Contact: diansan su, Dr.||+email@example.com|
|Shanghai, Shanghai, China, 200127|
|Contact: diansan su, Dr. +862168383702 firstname.lastname@example.org|
|Principal Investigator:||qi lu, Dr.||Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China|