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Completed

NCT Number: NCT03867994

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

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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Key information

Conditions

Contrast-induced Nephropathy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

atorvastatin

Drug

Carvedilol

Drug

Saline

Drug

Other names: 0.9%NaCl

Primary outcomes

  1. development of contrast induced nephropathy

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

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

Secondary outcomes

  1. Estimated Glomerular filtration rate (eGFR)

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

    Cockcroft-Gault equation was used to calculate (eGFR)

Other outcomes

  1. Blood urea nitrogen (BUN)

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

    BUN was assayed using modified Urease-Berthelot Method (Egyptian company of biotechnology, Cairo. Egypt)

  2. Serum Neutrophil gelatinase - associated lipocalin (NGAL) Description: . NGAL was assayed by enzyme -linked immunosorbent assay ELISA (Glory Science Co., Ltd, CHINA).

    Time frame: Baseline was measured from venous blood before the initiation of hydration, and 4 hours after CC procedure.

    . NGAL was assayed by enzyme -linked immunosorbent assay ELISA (Glory Science Co., Ltd, CHINA).

Sponsors and collaborators

Lead sponsor

rabab ahmed mohamed

Other

Collaborators

  • Cairo University

Registry information

Official study title

Comparison of Carvedilol and Atorvastatin for Prevention of Contrast-Induced Nephropathy After Cardiac Catheterization

Acronym: CIN

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 8, 2019
Registry last updated
Mar 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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