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

NCT05386953 | Unknown

• 1 other identifier: H-2108-173-1248
• Study Type: observational
• Target: 1,440
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Liver DIsease; Liver Transplant; Complications; Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence of postoperative hemodialysis

  the first month after admission

• Early allograft dysfunction

  the first 7 postoperative days

• In-hospital mortality

  the first month after admission

• One-year mortality

  one year after transplantation

• Length of intensive care unit stay

  the first month after admission

Study Arms (2)

Balanced group

Patients who received balanced crystalloids of lactated Ringer's solution or plasma solution during liver transplantation surgery

Drug: Balanced crystalloid solution

Saline group

Patients who received only normal saline during liver transplantation surgery

Drug: Normal saline

Interventions

Normal saline DRUG

Patients received normal saline as a maintenance crystalloid during liver transplantation surgery.

Saline group

Balanced crystalloid solution DRUG

Patients received balanced crystalloids such as lactated Ringer's solution or Plasma solution as a maintenance crystalloid during liver transplantation surgery.

Also known as: Lactated Ringer's solution, Plasma solution

Balanced group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

End Stage Liver Disease; Liver Cirrhosis

Interventions

Saline Solution; Ringer's Lactate; stable plasma protein solution

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Won Ho Kim, MD, PhD

  Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital

  STUDY CHAIR

Central Study Contacts

Ji-yoon Jung, MD

CONTACT

82-2-2072-2469; jiyooning1030@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 15, 2022
• First Posted: May 24, 2022
• Study Start: April 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)