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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03563378
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Information provided by (Responsible Party):
RenJi Hospital

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.

Condition or disease Intervention/treatment Phase
Biliary Atresia Intrahepatic Syndromic Form Drug: Lactated Ringer Drug: Normal saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Length of mechanical ventilation [ Time Frame: up to 30 days after surgery ]
    Length of mechanical ventilation in ICU measured in hours

  2. ICU stay [ Time Frame: up to 30 days after surgery ]
    Days spend in ICU within 30 days

  3. 30 day mortality [ Time Frame: up to 30 days after surgery ]
    Patient mortality during the first 30 days after surgery

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03563378

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Contact: diansan su, Dr. +862168383702

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China, Shanghai
Renji Hospital Recruiting
Shanghai, Shanghai, China, 200127
Contact: diansan su, Dr.    +862168383702   
Sponsors and Collaborators
RenJi Hospital
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Principal Investigator: qi lu, Dr. Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China

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Responsible Party: RenJi Hospital Identifier: NCT03563378     History of Changes
Other Study ID Numbers: 2017-162
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Biliary Atresia
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Digestive System Abnormalities
Congenital Abnormalities
Pharmaceutical Solutions