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

rabab ahmed mohamed

Status and phase: Completed; Phase 2

Conditions: Contrast-induced Nephropathy

Treatments: Drug: Atorvastatin; Drug: saline; Drug: Carvedilol

Study type: Interventional

Funder types: Other

Identifiers

NCT03867994

beta-blockers and statins

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 144 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 3 patient groups

Group (A)

Experimental group

Description:

included 49 patients who received high dose statin (80 mg atorvastatin) 12 hours before CC and 40 mg just before CC +hydration with saline (0.9% NaCl) at 0.5-1 mg/kg/hour for 4-6 hours before and 4-6 hours after cardiac catheterization.

Treatment:

Drug: Atorvastatin

Drug: saline

Group (B)

Experimental group

Description:

included 48 patients who received 12.5 mg carvedilol twice daily for 7 days before CC and continued for 24 hours after the CC +hydration with saline (0.9% NaCl) at 0.5-1 mg/kg/hour for 4-6 hours before and 4-6 hours after cardiac catheterization.

Treatment:

Drug: Carvedilol

Drug: saline

Group (C)

Experimental group

Description:

included 47 patients who did not receive any medications but only hydration with saline (0.9% NaCl) at 0.5-1 mg/kg/hour for 4-6 hours before and 4-6 hours after cardiac catheterization

Treatment:

Drug: saline