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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06459362
• Other study ID #: SSAS
• Status: Not yet recruiting
• Start date: July 1, 2024
• Est. completion date: July 1, 2027

Study information

• Verified date: June 2024
• Source: Assiut University
• Contact: shrouk sayed ahmed
• Phone: +201123232632
• Email: shrookabozaid[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevention and screening for early detection of acute kidney injury	using serum levels of Cystatin C (CysC) as early biomarkers for the identification of patients who are prone to AKI after cardiac inteventional surgeries as primary percutaneous coronary intervention (PCI)	2 years