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

1 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Descripción detallada

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 de estudio

De observación

Inscripción (Actual)

1416

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Ghent, Bélgica, 9000
        • Ghent University Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The association between KDIGO AKI stage and measured creatinine clearance.
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The association between KDIGO AKI 'urine output criteria' and 'serum creatinine criteria' and the measured creatinine clearance.
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de abril de 2026

Finalización primaria (Actual)

19 de abril de 2026

Finalización del estudio (Actual)

19 de abril de 2026

Fechas de registro del estudio

Enviado por primera vez

20 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

1 de junio de 2026

Publicado por primera vez (Actual)

3 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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