Intraoperative Normal Saline Administration and Acute Kidney Injury in Patients Undergoing Liver Transplantation

Intraoperative Normal Saline Administration and Acute Kidney Injury in Patients Undergoing Liver Transplantation: a Retrospective Cohort Study

The investigators attempted to investigate the association of the type of crystalloid administered during liver transplantation with postoperative clinical outcomes. The investigators hypothesized that the greater amount of normal saline or half-saline administered during liver transplantation might be associated with the increased risk of acute kidney injury compared to the balanced crystalloids.

Study Overview

• Status: Recruiting
• Conditions: Liver Cirrhosis; Liver Transplant; Complications; End Stage Liver DIsease
• Intervention / Treatment: Drug: Balanced crystalloid solution; Drug: Normal saline

Detailed Description

Liver transplantation requires a long operation time and is often associated with a significant amount of surgical bleeding. It is common for the anesthesiologist to infuse large amounts of fluid or blood products due to bleeding, hemodynamic instability, or ascites drainage. Therefore, in the anesthesia for liver transplantation, optimal management of fluid administration is necessary and the choice of the type of crystalloid may affect the prognosis or the incidence of postoperative complications of patients.

The investigators attempted to investigate the association of the type of crystalloid administered during liver transplantation with postoperative clinical outcomes. The investigators hypothesized that the greater amount of normal saline or half-saline administered during liver transplantation might be associated with the increased risk of acute kidney injury compared to the balanced crystalloids.

• Study Type: Observational
• Enrollment (Anticipated): 1440

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Ji-Yoon Jung, MD; Phone Number: 2462 82-2-2072-2462; Email: jiyooning1030@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients received liver transplantation surgery in a single tertiary care university hospital

Description

Inclusion Criteria:

• Consecutive patients who underwent living or deceased donor liver transplantation at our tertiary care university hospital between 2004 and 2018

Exclusion Criteria:

• patients with baseline renal dysfunction of hepatorenal syndrome or chronic kidney disease
• missing preoperative serum creatinine value
• missing other baseline or outcome variables
• patients who received retransplantation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Balanced group; Patients who received balanced crystalloids of lactated Ringer's solution or plasma solution during liver transplantation surgery	Drug: Balanced crystalloid solution; Patients received balanced crystalloids such as lactated Ringer's solution or Plasma solution as a maintenance crystalloid during liver transplantation surgery.; Other Names: Lactated Ringer's solution; Plasma solution
Saline group; Patients who received only normal saline during liver transplantation surgery	Drug: Normal saline; Patients received normal saline as a maintenance crystalloid during liver transplantation surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute kidney injury	The investigators defined acute kidney injury by the KDIGO (Kidney Disease Improving Global Outcomes) criteria, which was determined according to the greatest change in serum creatinine level during the postoperative seven days (Stage 1: more than 1.5-fold; stage 2: more than 2-fold; stage 3: more than 3-fold increase of baseline or increase in SCr to ≥ 4.0 mg/dL or the initiation of renal replacement therapy). The most recent SCr level measured before surgery was collected as a baseline value.	the first 7 postoperative days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative hemodialysis	the incidence of new-onset postoperative hemodialysis during hospitalization	the first month after admission
Early allograft dysfunction	One or more of the following are present within the first 7 postoperative days: total bilirubin ≥ 10 mg/dL, PT (prothrombin time):INR (international normalized ratio)≥ 1.6, or AST (aspartate aminotransferase)/ALT (alanine aminotransferase) > 2000 IU/L	the first 7 postoperative days
In-hospital mortality	all-cause mortality during hospitalization	the first month after admission
One-year mortality	all-cause mortality during one year after transplantation	one year after transplantation
Length of intensive care unit stay	Length of intensive care unit stay after transplantation	the first month after admission
Length of hospital stay	Length of hospital stay after transplantation	the first month after admission

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2022
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: May 15, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (ACTUAL): May 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Pathologic Processes; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Fibrosis; Liver Diseases; End Stage Liver Disease; Liver Cirrhosis; Acute Kidney Injury; Pharmaceutical Solutions
• Other Study ID Numbers: H-2108-173-1248

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No