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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05386953
• Other study ID #: H-2108-173-1248
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: Seoul National University Hospital
• Contact: Ji-yoon Jung, MD
• Phone: 82-2-2072-2469
• Email: jiyooning1030[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1440
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• End Stage Liver Disease
• Liver Cirrhosis
• Liver Diseases
• Liver Transplant; Complications

Intervention

Drug:
• Normal saline
Patients received normal saline as a maintenance crystalloid during liver transplantation surgery.
• Balanced crystalloid solution
Patients received balanced crystalloids such as lactated Ringer's solution or Plasma solution as a maintenance crystalloid during liver transplantation surgery.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of postoperative hemodialysis	the incidence of new-onset postoperative hemodialysis during hospitalization	the first month after admission
Secondary	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
Secondary	In-hospital mortality	all-cause mortality during hospitalization	the first month after admission
Secondary	One-year mortality	all-cause mortality during one year after transplantation	one year after transplantation
Secondary	Length of intensive care unit stay	Length of intensive care unit stay after transplantation	the first month after admission
Secondary	Length of hospital stay	Length of hospital stay after transplantation	the first month after admission