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

NCT ID: NCT06459362

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2027-07-01

Brief Summary

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.

Conditions

Acute Kidney Injury

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Serum cystatin C

Diagnostic test for detection of acute kidney injury

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years.

2. 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)

3. Patient with reduction in urine output (documented oliguria < 0.5 ml/kg/hour for > 6 hours)

4. Patient with typical chest pain, ECG changes, Echocardiogram positive finding

Exclusion Criteria

1. History of nephrectomy

2. patient with renal transplantation

3. patient with renal replacement therapy initiated before admission

4. patient with chronic kidney disease

5. patient on regular haemodialysis

6. patient known to be diabetic

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Shrook S. Ahmed

Demonstrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

shrouk sayed ahmed

Role: CONTACT

shrookabozaid@gmail.com

+201123232632

shrouk sayed ahmed

Role: CONTACT

shrookabozaid@gmail.com

01123232632

Other Identifiers

SSAS

Identifier Type: -

Identifier Source: org_study_id