Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT03563378
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

Tracking Information
First Submitted Date  ICMJE May 21, 2018
First Posted Date  ICMJE June 20, 2018
Last Update Posted Date June 20, 2018
Estimated Study Start Date  ICMJE July 28, 2018
Estimated Primary Completion Date May 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Intraoperative Normal Saline vs Lactated Ringer on Outcomes in Pediatric Liver Transplantation
Official Title  ICMJE Effects of Intraoperative Normal Saline vs Lactated Ringer on Outcomes in Pediatric Liver Transplantation: A Double-blind Randomized Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Biliary Atresia Intrahepatic Syndromic Form
Intervention  ICMJE
  • Drug: Lactated Ringer
    Patients will be administered Lactated Ringer's solution for intraoperative fluid management.
  • Drug: Normal saline
    Patients will be administered normal saline for intraoperative fluid management.
Study Arms  ICMJE
  • Experimental: Lactated ringers solution
    Participants in this group will receive Lactated Ringer's solution during the intraoperative period.
    Intervention: Drug: Lactated Ringer
  • Experimental: Normal saline solution
    Participants in this group will receive Normal saline solution during the intraoperative period.
    Intervention: Drug: Normal saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 19, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 27, 2020
Estimated Primary Completion Date May 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: diansan su, Dr. +862168383702 diansansu@yahoo.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03563378
Other Study ID Numbers  ICMJE 2017-162
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party RenJi Hospital
Study Sponsor  ICMJE RenJi Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: qi lu, Dr. Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
PRS Account RenJi Hospital
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP