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

NCT05540184 | Unknown Phase 4

• 1 other identifier: Allopurinol/Trimetazidine AKI
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Trimetazidine; Allopurinol; acute kidney injury; PCI

Outcome Measures

Primary Outcomes (1)

• Incidence of CIN

  Incidence of CIN

  48-72 hours after PCI

Secondary Outcomes (4)

• Change in SCr, within 48 hrs after the procedure

  within 48 hrs after the procedure

• Change in BUN within 48 hrs after the procedure

  within 48 hrs after the procedure

• Change in uric acid within 48 hrs after the procedure

  within 48 hrs after the procedure

• Change in eGFR within 48 hrs after the procedure

  within 48 hrs after the procedure

Study Arms (3)

Hydration plus Trimetazidine

EXPERIMENTAL

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

Drug: Trimetazidine 35 mg; Drug: Normal saline

Hydration ,Trimetazidine & allopurinol

EXPERIMENTAL

Hydration plus Trimetazidine 35mg once daily will be given to patients before the procedure and up to 24 hours after the procedure and allopurinol 300 mg once daily 5 hours before the procedure and next day of the procedure

Drug: Trimetazidine 35 mg; Drug: Allopurinol 300 MG; Drug: Normal saline

Hydration

PLACEBO COMPARATOR

Hydration only will be given to the patients normal saline at the 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)

Drug: Normal saline

Interventions

Trimetazidine 35 mg DRUG

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

Also known as: Vastarel MR

Hydration ,Trimetazidine & allopurinol; Hydration plus Trimetazidine

Allopurinol 300 MG DRUG

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

Also known as: Zyloric 300mg

Hydration ,Trimetazidine & allopurinol

Normal saline DRUG

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)

Also known as: 0.9 NS

Hydration; Hydration ,Trimetazidine & allopurinol; Hydration plus Trimetazidine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients willing to undergo PCI with low, moderate or high risk of CIN based on Mehran risk score (4)
• Age 18 - 80 years
• Patients with GFR \> 60 ml/min

You may not qualify if:

• Age \<18 or \> 80 years
• Acute kidney injury
• Renal insufficiency (eGFR \< 60 mL/min)
• Gout (serum uric \> 10 mg/dL)
• History of allopurinol intake.
• Hepatic failure.
• Pregnancy or lactation,
• History of allergy to contrast agents, allopurinol or trimetazidine
• Any nephrotoxic drug intake within 48 hrs. before the procedure
• Pulmonary edema, cardiogenic shock and mechanical ventilation.

Sponsors & Collaborators

• Beni-Suef University: lead
• Cairo University: collaborator

Study Sites (1)

Faculty of Pharmacy, Beni-Suef University

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Trimetazidine; Allopurinol; Saline Solution

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Mohamed Emam abd Elmobdy, Professor

  clinical pharmacy Beni-Suef university

  STUDY CHAIR

• Naglaa Samir Bazan, Assoc. Prof

  clinical pharmacy critical care medicine, Cairo university

  PRINCIPAL INVESTIGATOR

• Hatem Hossam Mowafi, Doctor

  Lecturer critical care medicine , Cairo university

  PRINCIPAL INVESTIGATOR

• Hadeer Safwat Hassan Zaki, Doctor

  Clinical Pharmacy, Beni-Suef University

  STUDY DIRECTOR

• Nourhan Osama Ali Moselhy, BSc

  Egyptian Drug Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nourhan Osama Ali Moselhy, BSc

CONTACT

01117115773; norhanossama15@yahoo.com

Naglaa Samir Bazan, Assoc. Prof

CONTACT

01005807504; naglaabazan@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Pharmacy, Beni-Suef University

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 14, 2022
• Study Start: September 19, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)