NCT04041323

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

2 years

First QC Date

July 30, 2019

Last Update Submit

November 29, 2021

Conditions

Keywords

AKIKDIGOICUpostoperative

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • ICU length of stay

    1 year

  • receipt and duration of mechanical ventilation

    1 year

  • receipt and duration of renal replacement therapy

    1 year

  • 1-year all cause mortality

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

retrospective data analysis of postoperative ICU patients admitted to anaesthesiological and surgical ICUs of the General Hospital Vienna, Austria between January 1, 2016 and December 31, 2018.

You may qualify if:

  • age \> 18 years
  • postoperative ICU admission
  • preoperative serum creatinine within 2 weeks prior surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Austria

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 30, 2019

First Posted

August 1, 2019

Study Start

June 13, 2019

Primary Completion

June 30, 2021

Study Completion

July 30, 2021

Last Updated

November 30, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations