Incidence and Outcomes of Acute Kidney Injury in Postoperative ICU Patients - a Retrospective Data Analysis

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT04041323
Collaborator
(none)
5,000
1
25.6
195.6

Study Details

Study Description

Brief Summary

Acute kidney injury (AKI) is a common complication in critically ill patients. Based on the sensitive KDIGO criteria, the incidence of AKI on ICU varies between 30-60 %. These large variations of incidence of AKI are due to different baseline characteristics of studied patients, the length of observation period, use of creatinine criteria only or use of creatinine and urine output criteria. Furthermore, back estimation of baseline creatinine instead of measured creatinine in patients with missing laboratory values may lead to overestimation of AKI severity and outcomes. Major surgery, trauma, infection, sepsis or a complication of severe illness can lead to an abrupt decrease in glomerular filtration in critically ill patients. Such episode of AKI is associated with short term adverse effects such as fluid overload, electrolyte imbalance, acid-base derangements, immune dysfunction, coagulation abnormalities and alterations in mental status. Additionally, AKI in critically ill patients leads to prolonged ICU length of stay, increase in morbidity and mortality as well as higher costs. Multiple large studies found, after correction for potential confounders, that AKI was independently associated with worse outcomes. Moderate and severe AKI stages were associated with 2.9 - 6.9 fold increased in-hospital mortality (3). Increasing AKI severity in ICU patients was not only associated with increased mortality, AKI patients had also worse renal function at the time of hospital discharge. The individual condition leading to AKI in combination with increased susceptibility to AKI may significantly influence outcome. Indeed, current data from many studies show that mortality from AKI differs in various clinical settings.

However, there are not enough data on different types of surgery and their effect on AKI yet. The aim of our epidemiological study is to investigate the occurrence and outcomes of AKI in different types of surgery in postoperative ICU patients at the Vienna General Hospital.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    5000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Incidence and Outcomes of Acute Kidney Injury in Postoperative ICU Patients - a Retrospective Data Analysis
    Actual Study Start Date :
    Jun 13, 2019
    Actual Primary Completion Date :
    Jun 30, 2021
    Actual Study Completion Date :
    Jul 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. 28 day mortality [28 days]

      primary outcome is the 28-day mortality in different stages of AKI according to KDIGO criteria in patients admitted in the ICU after surgery.

    Secondary Outcome Measures

    1. ICU length of stay [1 year]

      secondary outcomes are length of stay in the ICU, receipt and duration of mechanical ventilation, receipt and duration of renal replacement therapy and 1- year all-cause mortality

    2. receipt and duration of mechanical ventilation [1 year]

    3. receipt and duration of renal replacement therapy [1 year]

    4. 1-year all cause mortality [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • age > 18 years

    • postoperative ICU admission

    • preoperative serum creatinine within 2 weeks prior surgery

    Exclusion Criteria:
    • age < 18 years

    • no surgery prior to ICU admission

    • renal transplantation prior ICU admission

    • chronic renal replacement therapy

    • peritoneal dialysis

    • missing preoperative serum creatinine within 2 weeks prior surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University of Vienna Vienna Austria

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    PD Peter Faybik, MD, Principal Investigator, Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT04041323
    Other Study ID Numbers:
    • EK Nr. 1419/2019
    First Posted:
    Aug 1, 2019
    Last Update Posted:
    Nov 30, 2021
    Last Verified:
    Nov 1, 2021
    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
    Keywords provided by PD Peter Faybik, MD, Principal Investigator, Medical University of Vienna
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 30, 2021