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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05386953
Collaborator
(none)
1,440
1
9
160

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Normal saline
  • Drug: Balanced crystalloid solution

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 Design

Study Type:
Observational
Anticipated Enrollment :
1440 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Intraoperative Normal Saline Administration and Acute Kidney Injury in Patients Undergoing Liver Transplantation: a Retrospective Cohort Study
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm 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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Incidence of postoperative hemodialysis [the first month after admission]

      the incidence of new-onset postoperative hemodialysis during hospitalization

    2. 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

    3. In-hospital mortality [the first month after admission]

      all-cause mortality during hospitalization

    4. One-year mortality [one year after transplantation]

      all-cause mortality during one year after transplantation

    5. Length of intensive care unit stay [the first month after admission]

      Length of intensive care unit stay after transplantation

    6. Length of hospital stay [the first month after admission]

      Length of hospital stay after transplantation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 03080

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Study Chair: Won Ho Kim, MD, PhD, Department of Anaesthesiology and Pain Medicine, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Won Ho Kim, MD, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT05386953
    Other Study ID Numbers:
    • H-2108-173-1248
    First Posted:
    May 24, 2022
    Last Update Posted:
    May 27, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 27, 2022