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CompletedNCT04603664Updated Sep 13, 2021

Role of NGAL and Cystatin C in Prediction of Acute Kidney Injury Covid-19 Infection

An observational study in Biochemical Markers ,NGAL,Cystatin c, Acute Kidneyinjury, Covid 19, sponsored by Ain Shams University. Completed at 2 sites in Egypt. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-09-13.

Sponsored by Ain Shams University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 85 Years
Sex
All
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Study summary

Recent different biomarkers of acute kidney injury (AKI) have been manufactured by pharmaceutical industry. Studies proved that Neutrophil gelatinase-associated lipocalin (NGAL) and cystatin c are effective predictive biomarkers for early acute kidney injury in septic patients and in children after cardiopulmonary bypass. This study hypothesize that both cystatin c and Neutrophil gelatinase-associated lipocalin can predict AKI in patients with COVID-19 before elevation of serum urea and creatinine which may help early interference.

Read the detailed description

Since December 2019, a novel coronavirus called SARSCoV-2 (severe acute respiratory syndrome coronavirus 2) has caused an international outbreak of respiratory illness described as COVID-19. Among 85 patients with COVID-19 an incidence of acute kidney injury was reported to be 23%. The kidney histology from autopsies of six patients showed severe acute tubular necrosis with macrophage and lymphocyte infiltration. Another important paper revealed prominent acute proximal tubular injury, accumulation of peritubular erythrocyte and glomerular fibrin microthrombi after autopsy. However, this kidney injury was not detected by routine measures (creatinine and/or BUN) in some patients denoting subclinical kidney injury. The pathophysiology of AKI associated with COVID-19 could be due to specific mechanisms such as direct cell injury from viral entrance through highly expressed renal ACE2 receptors. Also pro-inflammatory cytokines, an imbalanced renin-angotensin-aldosterone system and thrombotic events are accused in renal damage. Non-specific mechanisms include hypovolemia, haemodynamic changes, right heart failure, high levels of PEEP in mechanically ventilated patients, nephrotoxic drugs and nosocomial infections. A significant association between kidney failure and death was documented in five studies. Hypoxemia and impairment of gas exchange has been identified as elements associated with AKI in patients with acute respiratory distress syndrome (ARDS).

Studies focusing on AKI with COVID-19 are needed urgently in order to identify the mechanism of renal affection and to predict the risk of AKI. Pharmaceutical industries with academia have made a lot of progress in the field of sensitive and specific preclinical biomarkers of kidney injury. Neutrophil gelatinase-associated lipocalin (NGAL) is composed of 178 amino acids. this glycoprotein is reabsorbed in the proximal tubules after its filtration through the glomeruli.

In a mouse model of renal ischemia, NGAL gene was rapidly expressed and upregulated within 3 hours of injury. The NGAL mRNA level increased more than 1000-fold 24-48 hours after injury. Thus, NGAL can be a useful tool to diagnose infection mediated AKI. Nonglycosylated Cystatin C is a protein produced by nucleated cells at constant rate. It is easily filtered through the glomeruli due to its positive charge at physiological pH and its low molecular weight. Then, it is reabsorbed and completely catabolized in the proximal tubules. Use of serum cystatin C as a marker of glomerular filtration rate (GFR) is well documented, and some authors have suggested that it may be more accurate than serum creatinine for this purpose. Complete evaluation of the clinical and laboratory picture of COVID-19 associated AKI is crucial to design preventive strategies and to suggest targeted interventions

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Conditions studied

  • Biochemical Markers ,NGAL,Cystatin c, Acute Kidneyinjury, Covid 19

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In context

COVID-19

7,775 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 100 is below the median of 260 across 3,188 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,932 studies on the registry; 433 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

adult patients from 18-85 diagnosed as covid 19 infection by nasaopharyngeal swap

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • person with the one of the following symptoms: fever and respiratory symptoms with radiological findings of pneumonia compatible with COVID-19

    1. Respiratory distress (≥ 30 breaths/ min);
    2. Oxygen saturation ≤ 93% at rest;
    3. Arterial partial pressure of oxygen (PaO2)/ fraction of inspired oxygen (FIO2) ≤ 300.
    4. Cases with chest imaging that shows obvious lesion progression within 24-48 hours > 50%.
    5. Respiratory failure and requiring mechanical ventilation;
    6. Shock;
    7. other organ failure that requires ICU care.

Exclusion criteria

Exclusion Criteria:

  • patients classified as mild corona virsus disease, patients with end-stage renal disease (ESRD) or on chronic regular dialysis, presence of AKI and anuria at the time of ICU admission, history of chronic kidney disease, severe urinary tract infection, kidney malignancy, and renal transplantation.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • study group

    blood sampling and measduring of serum NGAL and cystatin c on admission and after 48 hours and creatinine every day

    Diagnostic Test: serum NGAL and cystatin c

Interventions

  • Diagnostic testserum NGAL and cystatin c

    measuring serum NGAL and cystatin c on admission and after 48 hours in critically ill patients with covid 19 then compare results to serum creatinine and signs of acute kidney injury

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What researchers measure

Primary outcomes

  1. measure both cystatin c and Neutrophil gelatinase-associated lipocalin on admission and after 48 hours. (NGAL) as recent biomarkers in prediction of AKI in patients with COVID-19.

    biochmical tests for detection of NGAL and Cystatin c in crirically ill Covid 19 patients

    Time frame: 12 days starting from hospital admission

Secondary outcomes

  1. development of acute kidney injury lipocalin (NGAL) to AKI severity and prognosis of AKI in patients with COVID-19 infection

    increased serum creatinine

    Time frame: 12 days starting from day of admission

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Study locations

2 sites
  • Ainshams hospitals
    Cairo, 11591, Egypt
  • Sanaa Wasfy
    New Cairo, 11865, Egypt
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References and documents

Publications

  • Diao, C.H. Wang, R.S. Wang, Z.Q. Feng, Y.J. Tan, H.M. Wang, et al. ( 2020 ) Human kidney is a target for novel severe acute respiratory syndrome coronavirus 2[SARS-CoV-2] infection [preprint posted online April 10, . medRxiv doi:10.1101/2020.03.04.20031120 Xu S, Fu L, Fei J et al (2020) Acute kidney injury at early stage as a negative prognostic indicator of patients with COVID-19: a hospital-based retrospective analysis. medRxiv 2020.03.24.20042408. https://doi.org/10.1101/2020.03.24.20042408 Darmon M, Schortgen F, Leon R et al (2009) Impact of mild hypoxemia on renal function and renal resistive index during mechanical ventilation. Intensiv Care Med 35:1031-1038. https://doi.org/10.1007/s00134-008-1372-5 Darmon M, Schortgen F, Leon R et al (2009) Impact of mild hypoxemia on renal function and renal resistive index during mechanical ventilation. Intensiv Care Med 35:1031-1038. https://doi.org/10.1007/s00134-008-1372-5

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04603664
Responsible party
Sanaa Farag Mahmoud Wasfy (lecturer of aneathesia, Ain Shams University) — Principal investigator
First posted
Oct 27, 2020
Start date
Oct 30, 2020
Primary completion
Jun 30, 2021
Completion
Jun 30, 2021
Last update
Sep 13, 2021

Study contacts

sanaa wasfy
principal investigator · lecturer

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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