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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04041323
Other study ID # EK Nr. 1419/2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 13, 2019
Est. completion date July 30, 2021

Study information

Verified date November 2021
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 5000
Est. completion date July 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary 28 day mortality primary outcome is the 28-day mortality in different stages of AKI according to KDIGO criteria in patients admitted in the ICU after surgery. 28 days
Secondary ICU length of stay 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 1 year
Secondary receipt and duration of mechanical ventilation 1 year
Secondary receipt and duration of renal replacement therapy 1 year
Secondary 1-year all cause mortality 1 year
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