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

NCT ID: NCT03563378

Last Updated: 2018-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-28

Study Completion Date

2020-05-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Biliary Atresia Intrahepatic Syndromic Form

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Lactated ringers solution

Participants in this group will receive Lactated Ringer's solution during the intraoperative period.

Group Type EXPERIMENTAL

Lactated Ringer

Intervention Type DRUG

Patients will be administered Lactated Ringer's solution for intraoperative fluid management.

Normal saline solution

Participants in this group will receive Normal saline solution during the intraoperative period.

Group Type EXPERIMENTAL

Normal saline

Intervention Type DRUG

Patients will be administered normal saline for intraoperative fluid management.

Interventions

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Lactated Ringer

Patients will be administered Lactated Ringer's solution for intraoperative fluid management.

Intervention Type DRUG

Normal saline

Patients will be administered normal saline for intraoperative fluid management.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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qi lu, Dr.

Role: PRINCIPAL_INVESTIGATOR

Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China

Locations

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Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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diansan su, Dr.

Role: CONTACT

[email protected]
+862168383702

Facility Contacts

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diansan su, Dr.

Role: primary

[email protected]
+862168383702

Other Identifiers

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2017-162

Identifier Type: -

Identifier Source: org_study_id

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