Comparison of Carvedilol and Atorvastatin for Preventing of Contrast-Induced Nephropathy.

rabab ahmed mohamed144 enrolled

Overview

This prospective study is intended to evaluate if carvedilol has any potential protective effect over atorvastatin on the development of contrast-induced nephropathy (CIN) following cardiac catheterization in patients with moderate to high risk for CIN.

This study enrolled 150 patients planned for CC, and randomly assigned for one of the three groups. Group (A)include 49 patients who received two atorvastatin dose 80 mg 12 hours before CC and 40 mg just before CC. Group (B) include 48 patients who received 12.5 mg carvedilol twice daily for 7 days before CC and continue for 24hrs after the day of CC, Group (C) include 47 patients who only hydrated with saline. All included patients were hydrated with saline intravenous 0.9 sodium chloride (NaCl) at 0.5-1 mg/kg/hour for 4-6 hours before and 4-6 hours after cardiac catheterization. Serum creatinine(Scr), blood urea nitrogen (BUN) and estimated glomerular filtration rate were evaluated at the baseline and after 48 from CC. Serum neutrophil-associated lipocalin (NGAL) was evaluated after 4 hours from CC.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

144

Conditions

Contrast-induced Nephropathy

Interventions

AtorvastatinDRUG

CarvedilolDRUG

salineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged between 18 and 70 years. * Serum creatinine ≤ 1.5 mg/dL. * Using a moderate dose of atorvastatin (40 mg or equivalent dose of other statins). * Moderate to high-risk for CIN. Exclusion Criteria: * Patients suffering from ST-segment elevation myocardial infarction (STEMI) * Patients need for immediate cardiac catheterization * Elevated liver enzymes (Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) three times the upper limit of normal). * Active infection. * Any contraindication to carvedilol, or atorvastatin. * Patients on regular use of vitamins, minerals. * Using medication with antioxidant properties e.g., beta-carotene, vitamin E, vitamin C, selenium, theophylline or N-acetyl cysteine 7 days prior to CC. * Hemodynamically unstable patients (defined as abnormal or unstable blood pressure, especially hypotension (blood pressure less than 90/60 mm Hg). * Patients who required dialysis. * Pregnancy. * Using of carvedilol in the past three months. * Using a nephrotoxic agent in the past 48 hours or exposure to a contrast agent in the past 7 days prior to cardiac catheterization.

Outcomes

Primary Outcomes

development of contrast induced nephropathy

CIN :(defined as absolute rise in the baseline serum creatinine concentration by 0.5 mg/dL after 48 hours from CC).

Time frame: 1. Serum creatinine baseline was measured from venous blood (before initiating the hydration) and 48 hours after the CC procedure.

Secondary Outcomes

Estimated Glomerular filtration rate (eGFR)

Cockcroft-Gault equation was used to calculate (eGFR)

Time frame: on admission, and re-calculated 48 hours post CC using

Data from ClinicalTrials.gov

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