Allopurinol and Trimetazidine as a Preventive of Acute Kidney Injury in PCI Patients

Summary

Contrast-associated acute kidney injury (CA-AKI) is a common complication of procedures with intravascular contrast. Generally, CA-AKI is defined as serum creatinine (Scr) ≥ 25 to 50% or Scr rise around 0.3 to 0.5 mg/dl. The initial rise in SCr is typically seen within 48 to 72 h of contrast exposure .CA-AKI has been associated with increased hospital length of stay and excess costs. Therefore, the prevention of CA-AKI is beneficial for minimizing hospital costs, mortality and morbidity. Till now, what is clearly beneficial in CIN is adequate hydration before and after coronary angiography However, further measures are trialed, aiming to reduce more morbidity and mortality. There is a great deal of publications pertaining to the possible therapeutic interventions to avoid the ultimate outcome of complete kidney failure. Accordingly, allopurinol has been suggested as a promising measure for the prevention of acute kidney injury after coronary angiography through protecting the kidney by inhibiting XO activity and blocking the generation of oxygen radicals. However, studies have shown conflicting results. Trimetazidine is cellular anti-ischemic drug which has been shown to protect against free radical damage due to its antioxidant activity. It has been recently shown to decrease the risk of CIN in percutaneous coronary intervention (PCI) in some studies. However, it is worth mentioning that studies evaluating trimetazidine under presented patients with high estimated glomerular filtration rate (eGFR). Accordingly, Aimed to evaluate the combination of trimetazidine with allopurinol versus using trimetazidine alone to define the most effective strategy to be implemented in the clinical setting in patients with diverse risk factors and normal GFR.

Conditions

• AKI - Acute Kidney Injury

Interventions

DRUG

Trimetazidine 35 mg

Trimetazidine 35mg twice daily will be given to patients before the procedure and 24 hours after the procedure

DRUG

Allopurinol 300 MG

allopurinol 300 mg once daily 5 hours before the procedure and next day of the procedure

DRUG

Normal saline

rate of 1 mL/kg per hour (3 to 4 hrs before the procedure and up to 24 hours post-procedure, maximum 100 ml/hr)

Sponsors & Collaborators

• Cairo University

  collaborator OTHER

• Beni-Suef University

  lead OTHER

Principal Investigators

• Mohamed Emam abd Elmobdy, Professor · clinical pharmacy Beni-Suef university

• Naglaa Samir Bazan, Assoc. Prof · clinical pharmacy critical care medicine, Cairo university

• Hatem Hossam Mowafi, Doctor · Lecturer critical care medicine , Cairo university

• Hadeer Safwat Hassan Zaki, Doctor · Clinical Pharmacy, Beni-Suef University

• Nourhan Osama Ali Moselhy, BSc · Egyptian Drug Authority

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-19

Primary Completion

2025-09-30

Completion

2025-09-30

Countries

• Egypt

Study Locations