Acute Kidney InjuryNCT04041323
Incidence and Outcomes of Acute Kidney Injury in Postoperative ICU Patients - a Retrospective Data Analysis
An observational study of Acute Kidney Injury and ICU, run by Medical University of Vienna at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, ICU, Postoperative Patients
- How many people
- 5,000 participants
- Where
- 1 siteAustria
- Study dates
- 13 Jun 2019to 30 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- age > 18 years
- postoperative ICU admission
- preoperative serum creatinine within 2 weeks prior surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Acute Kidney Injury, ICU, Postoperative Patients
- Keywords
- AKI, KDIGO, ICU, postoperative
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (4)
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
Measured: 1 year
receipt and duration of mechanical ventilation
Measured: 1 year
receipt and duration of renal replacement therapy
Measured: 1 year
1-year all cause mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start13 Jun 2019
- Primary completion30 Jun 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Peter Faybik, MD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041323
- Sponsor's protocol ID
- EK Nr. 1419/2019
- Status last verified
- Nov 2021
- First submitted
- 30 Jul 2019
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Outcomes of Acute Kidney Injury in Postoperative ICU Patients - a Retrospective Data Analysis
- ClinicalTrials.gov ID
- NCT04041323
- Acronym / sponsor ID
- EK Nr. 1419/2019
- Conditions
- Acute Kidney Injury, ICU, Postoperative Patients
- Keywords
- AKI, KDIGO, ICU, postoperative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- age > 18 years
- postoperative ICU admission
- preoperative serum creatinine within 2 weeks prior surgery
Key exclusion criteria (6 listed)
- age < 18 years
- no surgery prior to ICU admission
- renal transplantation prior ICU admission
- chronic renal replacement therapy
- peritoneal dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
28 day mortality
Time frame: 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.
4 secondary outcomes
ICU length of stay
Time frame: 1 year
receipt and duration of mechanical ventilation
Time frame: 1 year
receipt and duration of renal replacement therapy
Time frame: 1 year
1-year all cause mortality
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and ICU, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28 day mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.