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Not yet recruiting NCT06459362

Serum Cystatin C for Early Detection of Acute Kidney Injury After Primary Percutaneous Coronary Intervention

Observational Acute Kidney Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Serum cystatin C.
Who it may be relevant to
Registry conditions: Acute Kidney Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This study aims to evaluate whether the serum levels of Cystatin C (CysC) can be used as early biomarkers for the identification of patients who are prone to AKI after cardiac interventional surgeries as primary percutaneous coronary intervention (PCI)

Detailed description

Acute Kidney Injury (AKI) is defined as an absolute increase in serum creatinine ≥0.3 mg/dl (≥26.4 μmol/l), a percentage increase in serum creatinine ≥50% (1.5-fold from baseline), or a reduction in urine output (documented oliguria \< 0.5 ml/kg/hour for \> 6 hours) Serum creatinine which is considered the gold standard currently for diagnosis of AKI remains unchanged until 50% of kidney function falls down. It is affected by non-specific factors like diet, age, dehydration, muscle mass, gender, and drugs There were evidences of the association between AKI and acute coronary syndrome (ACS); First, AKI detection may be missed by cardiologists. Physicians tend to disregard mild or transient serum creatinine elevation during hospital stay for ACS, and they often attribute small serum creatinine increases to laboratory variations.

Cystatin C (CysC), a cystatin protease inhibitor, is less affected by non-specific factors. When GFR decreases, CysC begins to increase. CysC was recommended to be measured in addition to creatinine in GFR estimation.

Interventions

  • Diagnostic test Serum cystatin C
    Diagnostic test for detection of acute kidney injury

Primary outcome measures

  • prevention and screening for early detection of acute kidney injury [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years.
  • Patient with absolute increase in serum creatinine ≥0.3 mg/dl (≥26.4 μmol/l) or with percentage increase in serum creatinine ≥50% (1.5-fold from baseline)
  • Patient with reduction in urine output (documented oliguria < 0.5 ml/kg/hour for > 6 hours)
  • Patient with typical chest pain, ECG changes, Echocardiogram positive finding

Exclusion criteria

  • History of nephrectomy
  • patient with renal transplantation
  • patient with renal replacement therapy initiated before admission
  • patient with chronic kidney disease
  • patient on regular haemodialysis
  • patient known to be diabetic

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06459362 · SSAS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗