Clinical trial NCT03867994: Comparison of Carvedilol and Atorvastatin for Preventing of Contrast-Induced Nephropathy.
Official title: Comparison of Carvedilol and Atorvastatin for Prevention of Contrast-Induced Nephropathy After Cardiac Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contrast-induced Nephropathy
Keywords: Cardiac catheterization, carvedilol, atorvastatin.
Lead sponsor: October 6 University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2019-03-08
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: development of contrast induced nephropathy
timeFrame: 1. Serum creatinine baseline was measured from venous blood (before initiating the hydration) and 48 hours after the CC procedure.
Secondary outcomes:
measure: Estimated Glomerular filtration rate (eGFR)
timeFrame: on admission, and re-calculated 48 hours post CC using
Other outcomes:
measure: Blood urea nitrogen (BUN)
timeFrame: On admission, and re-calculated 48 hours post CC using
measure: Serum Neutrophil gelatinase - associated lipocalin (NGAL) Description: . NGAL was assayed by enzyme -linked immunosorbent assay ELISA (Glory Science Co., Ltd, CHINA).
timeFrame: Baseline was measured from venous blood before the initiation of hydration, and 4 hours after CC procedure.
Locations:
Study officials:
References: