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Completed

NCT Number: NCT06064487

Renal Cell Arrest and Damage Biomarkers in Progression and Outcome of Septic AKI

The aim of the current study is to assess the predictive value of renal cell arrest biomarkers (urinary TIMP2 and IGFBP7), renal damage biomarkers (urinary KIM-1) and microscopic examination of urinary sediment in progression and outcome of sepsis associated AKI.

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Key information

About this study

Acute kidney injury occurred in about 45-53% of patients with sepsis, and most septic AKI was mild or moderate AKI (KDIGO stage 1 or stage 2).

However, previous study showed that up to 40% of these mild or moderate AKI would progress to more severe AKI (KDIGO stage 3), of which 30% required dialysis and the risk of death increased by 3-fold, as high as 70%. Therefore, early identifying patients at high risk for progressive AKI might help clinicians to enhance individualized monitoring and personalized management in patient with septic AKI, which might prevent or halt the ongoing renal injury and improve the outcome of patients with sepsis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • AKI stage 1 or 2 according to KDIGO definition.
  • Sepsis is defined based on the third international consensus definitions for sepsis and septic shock (Sepsis-3) as life threatening organ dysfunction caused by a dysregulated host response to infection. At least two of systemic inflammatory response syndrome (SIRS) criteria should be present

Exclusion criteria

  • Age less than 18 years.
  • Patients with pre-existing chronic kidney disease (eGFR<60 ml/min/1.73m2).
  • Previous renal replacement therapy.
  • Acute kidney injury caused by permanent postrenal obstruction.
  • Pregnancy.
  • Hepatorenal syndrome.
  • Renal transplant recipients.
  • Patients for whom survival to 30 days is unlikely due to end stage disease (end stage liver or heart disease or untreatable malignancy).

Treatment and study plan

renal cell arrest and damage biomarkers assessment

Diagnostic Test

measurement of TIMP2 and IGFBP7, KIM-1

Primary outcomes

  1. Urinary TIMP2 and IGFBP7 estimation

    Time frame: 90 days

    both will be measured by the ELISA technique

  2. Urinary KIM-1 estimation

    Time frame: 90 days

    will be measured by the ELISA technique

  3. Examination of urine sediment

    Time frame: 7 days

    by calculating Perazella score

  4. progression of AKI

    Time frame: 90 days

    by assessing change in eGFR

  5. Examination of urine sediment

    Time frame: 7 days

    by calculating Chawla score

Secondary outcomes

  1. need for renal replacement therapy

    Time frame: 90 days

    need of any dialysis modality

  2. mortality

    Time frame: 90 days

    death

  3. length of ICU and hospital stay

    Time frame: 90 days

    duration of stay

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Role of Renal Cell Arrest and Damage Biomarkers in Progression and Outcome of Sepsis Associated AKI

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2023
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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