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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2017-05-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Contrast-induced Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

the patients were selected randomly and divided for three groups prospectively. the design was single-blinded randomized controlled study at which the researcher was aware by the allocation of the groups while the patients were blinded.

Study Groups

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Group (A)

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.

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

saline

Intervention Type DRUG

Group (B)

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.

Group Type EXPERIMENTAL

Carvedilol

Intervention Type DRUG

saline

Intervention Type DRUG

Group (C)

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

Group Type EXPERIMENTAL

saline

Intervention Type DRUG

Interventions

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Atorvastatin

Intervention Type DRUG

Carvedilol

Intervention Type DRUG

saline

Intervention Type DRUG

Other Intervention Names

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0.9%NaCl

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No