AKI - Acute Kidney InjuryNCT07624721
The Relationship Between Measured Creatinine Clearance and Acute Kidney Injury in Critically Ill Patients
An observational study of AKI - Acute Kidney Injury, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
With this study, the investigators want to find out how well different stages of acute kidney injury (AKI), match with the actual filtering ability of the kidneys in very sick adults in the intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AKI - Acute Kidney Injury
- How many people
- 1,416 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2026to 19 Apr 2026
- 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: Adult patients admitted on the ICU of Ghent Univesity Hospital between 1 December 2024 and 30 November 2025
Who may be able to join
- Admission ICU of Ghent university hospital
- Availability of at least one serum creatinine clearance
Who cannot join
- chronic RRT before ICU admission
- RRT during ICU
- Missing or incomplete data preventing KDIGO AKI classification
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Relationship Between Measured Creatinine Clearace and KDIGO AKI Criteria in Critically Ill Patients - A Retrospective Single-Center Study
With this study, the investigators want to find out how well different stages of acute kidney injury (AKI), match with the actual filtering ability of the kidneys in very sick adults in the intensive care unit (ICU). Kidney function will be measured using a urine test that estimates how much waste the kidneys can clear from the blood.
The investigators will also compare two ways of diagnosing and staging AKI: one based on how much urine a person makes, and the other based on blood creatinine levels (a waste product that rises when kidney function worsens). In addition, the investigators will examine how factors that can be changed (such as treatments or medications) and factors that cannot be changed (such as age or existing health conditions) may affect this relationship.
Finally, the investigators will look at whether drops in kidney function are linked to problems like high potassium levels in the blood and a buildup of acid in the body.
Read the detailed description
The aim of this study is to investigate the relationship between the different stages of the KDIGO Acute Kidney Injury (AKI) criteria with measured creatinine Clearance using short-term creatinine clearance (Ccr) in critically ill adults admitted to the ICU. The investigators will also examine the difference between CCr and estimated Glomerular Filtration Rate (eGFR) and potential differences on this relationship when the urine output criteria are used versus when Scr is used for the diagnosis of the different AKI KDIGO stages. Additionally, the study will explore how modifiable and non-modifiable risk factors influence this relationship. Finally, we will evaluate how declines in GFR are associated with complications such as hyperkalemia and metabolic acidosis.
- Conditions
- AKI - Acute Kidney Injury
- Keywords
- intensive care, acute kidney injury
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between KDIGO AKI stage and measured creatinine clearance.
During each patient's entire ICU stay, the KDIGO stage will be determined at every time point for which a measured creatinine clearance value is available. As this is a retrospective analysis, the timing and frequency of measured creatinine clearance assessments will vary between patients throughout their ICU stay.
Measured creatine clearance will be corrected for body surface area and expressed as mL/min/1.73 m². The KDIGO classification categorizes AKI severity from mild to severe using a scoring system ranging from stage 1 to stage 3.
Measured: from ICU admission until ICU discharge (average 4 days)
Secondary outcomes (5)
The association between KDIGO AKI 'urine output criteria' and 'serum creatinine criteria' and the measured creatinine clearance.
During each patient's entire ICU stay, the KDIGO stage will be determined at every time point for which a measured creatinine clearance value is available. As this is a retrospective analysis, the timing and frequency of measured creatinine clearance assessments will vary between patients throughout their ICU stay. Differences according to the KDIGO severity classification and its subcriteria 'serum creatinine changes' or 'urine output changes' will be evaluated. Measured creatinine clearance will be corrected for body surface area and expressed in mL/min/1.73 m².
Measured: from ICU admission until ICU discharge (average 4 days)
The association of gender with differences in measured creatinine clearance according to AKI severity.
The association of gender on measured creatinine clearance within different stages of AKI (based on KDIGO classification).
During each patient's entire ICU stay, the KDIGO stage will be determined at every time point for which a measured creatinine clearance value is available. As this is a retrospective analysis, the timing and frequency of measured creatinine clearance assessments will vary between patients throughout their ICU stay. The gender of the patient is collected at ICU admission. Measured creatinine clearance will be corrected for body surface area and expressed in mL/min/1.73 m².
Measured: from ICU admission until ICU discharge (average 4 days)
Comparison of measured creatinine clearance in patients with chronic kidney disease (CKD) in the different AKI (KDIGO) stages
Comparison of measured creatinine clearance in patients with chronic kidney disease (CKD) versus those with normal baseline kidney function. Measured creatinine clearance will be compared in the different AKI KDIGO stages.
During each patient's entire ICU stay, the KDIGO stage will be determined at every time point for which a measured creatinine clearance value is available. As this is a retrospective analysis, the timing and frequency of measured creatinine clearance assessments will vary between patients throughout their ICU stay. The stage of chronic kindey disease at ICU admission will be collected .
Measured: from ICU admission until ICU discharge (average 4 days)
Association of measured creatinine clearance and KDIGO stage with complications
Association of measured creatinine clearance and KDIGO stage with complications, including: Hyperkalemia, Acidemia, Need for renal replacement therapy. Data about complications will be collected during the entire ICU stay of the patient.
Measured: from ICU admission until ICU discharge (average 4 days)
The association between measured creatinine clearance and estimated glomerular filtration rate (eGFR)
Estimated glomerular filtration rate (eGFR) is generally used to assess renal function in stable patients. In this study, eGFR will be evaluated in critically ill ICU patients and compared with measured creatinine clearance.
During each patient's entire ICU stay, the eGFR will be determined at every time point for which a measured creatinine clearance value is available. As this is a retrospective analysis, the timing and frequency of measured creatinine clearance assessments will vary between patients throughout their ICU stay.
Measured creatinine clearance will be corrected for body surface area and expressed in mL/min/1.73 m². eGFR is expressed in the same unit, mL/min/1.73 m².
Measured: from ICU admission until ICU discharge (average 4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Apr 2026
- Primary completion19 Apr 2026
- Study completion19 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AKI - Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- 1,416 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624721
- Sponsor's protocol ID
- ONZ-2025-0607
- Status last verified
- Jun 2026
- First submitted
- 20 Apr 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data of individuals will not be shared according to General Data Protection Regulation (GDPR)
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Relationship Between Measured Creatinine Clearace and KDIGO AKI Criteria in Critically Ill Patients - A Retrospective Single-Center Study
- ClinicalTrials.gov ID
- NCT07624721
- Acronym / sponsor ID
- ONZ-2025-0607
- Conditions
- AKI - Acute Kidney Injury
- Keywords
- intensive care, acute kidney injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,416 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 19 Apr 2026 (actual)
- Study completion
- 19 Apr 2026 (actual)
- First posted
- 3 Jun 2026 (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.
With this study, the investigators want to find out how well different stages of acute kidney injury (AKI), match with the actual filtering ability of the kidneys in very sick adults in the intensive care unit (ICU). Kidney function will be measured using a urine test that estimates how much waste the kidneys can clear from the blood.
The investigators will also compare two ways of diagnosing and staging AKI: one based on how much urine a person makes, and the other based on blood creatinine levels (a waste product that rises when kidney function worsens). In addition, the investigators will examine how factors that can be changed (such as treatments or medications) and factors that cannot be changed (such as age or existing health conditions) may affect this relationship.
Finally, the investigators will look at whether drops in kidney function are linked to problems like high potassium levels in the blood and a buildup of acid in the body.
Detailed description
The aim of this study is to investigate the relationship between the different stages of the KDIGO Acute Kidney Injury (AKI) criteria with measured creatinine Clearance using short-term creatinine clearance (Ccr) in critically ill adults admitted to the ICU. The investigators will also examine the difference between CCr and estimated Glomerular Filtration Rate (eGFR) and potential differences on this relationship when the urine output criteria are used versus when Scr is used for the diagnosis of the different AKI KDIGO stages. Additionally, the study will explore how modifiable and non-modifiable risk factors influence this relationship. Finally, we will evaluate how declines in GFR are associated with complications such as hyperkalemia and metabolic acidosis.
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
- Adult patients admitted on the ICU of Ghent Univesity Hospital between 1 December 2024 and 30 November 2025
Key inclusion criteria (2 listed)
- Admission ICU of Ghent university hospital
- Availability of at least one serum creatinine clearance
Key exclusion criteria (3 listed)
- chronic RRT before ICU admission
- RRT during ICU
- Missing or incomplete data preventing KDIGO AKI classification
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
The association between KDIGO AKI stage and measured creatinine clearance.
Time frame: from ICU admission until ICU discharge (average 4 days)
During each patient's entire ICU stay, the KDIGO stage will be determined at every time point for which a measured creatinine clearance value is available. As this is a retrospective analysis, the timing and frequency of measured creatinine clearance assessments will vary between patients throughout their ICU stay. Measured creatine clearance will be corrected for body surface area and expressed as mL/min/1.73 m². The KDIGO classification categorizes AKI severity from mild to severe using a scoring system ranging from stage 1 to stage 3.
5 secondary outcomes
The association between KDIGO AKI 'urine output criteria' and 'serum creatinine criteria' and the measured creatinine clearance.
Time frame: from ICU admission until ICU discharge (average 4 days)
The association of gender with differences in measured creatinine clearance according to AKI severity.
Time frame: from ICU admission until ICU discharge (average 4 days)
Comparison of measured creatinine clearance in patients with chronic kidney disease (CKD) in the different AKI (KDIGO) stages
Time frame: from ICU admission until ICU discharge (average 4 days)
Association of measured creatinine clearance and KDIGO stage with complications
Time frame: from ICU admission until ICU discharge (average 4 days)
The association between measured creatinine clearance and estimated glomerular filtration rate (eGFR)
Time frame: from ICU admission until ICU discharge (average 4 days)
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 3 Jun 2026.
- Individual participant dataSharing planned: No. Data of individuals will not be shared according to General Data Protection Regulation (GDPR)
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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 AKI - Acute Kidney Injury, run by University Hospital, Ghent at 1 site in Belgium.
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 2 inclusion and 3 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 3 Jun 2026. 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 Belgium. 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?
The association between KDIGO AKI stage and measured creatinine clearance. (time frame: from ICU admission until ICU discharge (average 4 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 3 Jun 2026.