- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07624721
The Relationship Between Measured Creatinine Clearance and Acute Kidney Injury in Critically Ill Patients
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Ghent, Belgium, 9000
- Ghent University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- Admission ICU of Ghent university hospital
- Availability of at least one serum creatinine clearance
Exclusion Criteria:
- chronic RRT before ICU admission
- RRT during ICU
- Missing or incomplete data preventing KDIGO AKI classification
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
from ICU admission until ICU discharge (average 4 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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.
|
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)
|
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. |
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)
|
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 . |
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)
|
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.
|
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)
|
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. |
from ICU admission until ICU discharge (average 4 days)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ONZ-2025-0607
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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