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The Relationship Between Measured Creatinine Clearance and Acute Kidney Injury in Critically Ill Patients

1 giugno 2026 aggiornato da: University Hospital, Ghent

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.

Panoramica dello studio

Stato

Completato

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

1416

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Ghent, Belgio, 9000
        • Ghent University Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Adult patients admitted on the ICU of Ghent Univesity Hospital between 1 December 2024 and 30 November 2025

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The association between KDIGO AKI stage and measured creatinine clearance.
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The association between KDIGO AKI 'urine output criteria' and 'serum creatinine criteria' and the measured creatinine clearance.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 aprile 2026

Completamento primario (Effettivo)

19 aprile 2026

Completamento dello studio (Effettivo)

19 aprile 2026

Date di iscrizione allo studio

Primo inviato

20 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 giugno 2026

Primo Inserito (Effettivo)

3 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Data of individuals will not be shared according to General Data Protection Regulation (GDPR)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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