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

• Conditions: End Stage Liver DIsease; Liver Transplant; Complications; Liver Cirrhosis
• Interventions: Drug: Balanced crystalloid solution; Drug: Normal saline

• Registration Number: NCT05386953
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2022-04-01
• Status Verified: 2022-05
• Study First Submitted: 2022-05-15
• Study First Submitted QC: 2022-05-18
• Last Update Submitted: 2022-05-23
• Study First Posted: 2022-05-24
• Last Update Posted: 2022-05-27
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1440

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Balanced group	Balanced crystalloid solution	Patients who received balanced crystalloids of lactated Ringer's solution or plasma solution during liver transplantation surgery
Saline group	Normal saline	Patients who received only normal saline during liver transplantation surgery

Primary Outcome Measures

Name	Time	Method
Acute kidney injury	the first 7 postoperative days	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.

Secondary Outcome Measures

Name	Time	Method
One-year mortality	one year after transplantation	all-cause mortality during one year after transplantation
Length of intensive care unit stay	the first month after admission	Length of intensive care unit stay after transplantation
Length of hospital stay	the first month after admission	Length of hospital stay after transplantation
In-hospital mortality	the first month after admission	all-cause mortality during hospitalization
Incidence of postoperative hemodialysis	the first month after admission	the incidence of new-onset postoperative hemodialysis during hospitalization
Early allograft dysfunction	the first 7 postoperative days	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of