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

March 8, 2019 updated by: rabab ahmed mohamed

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Atorvastatin
Drug: saline
Other Names:
  • 0.9%NaCl
EXPERIMENTAL: 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.
Drug: Carvedilol
Drug: saline
Other Names:
  • 0.9%NaCl
EXPERIMENTAL: 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
Drug: saline
Other Names:
  • 0.9%NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1. Serum creatinine baseline was measured from venous blood (before initiating the hydration) and 48 hours after the CC procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
on admission, and re-calculated 48 hours post CC using

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
On admission, and re-calculated 48 hours post CC using
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).
Baseline was measured from venous blood before the initiation of hydration, and 4 hours after CC procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

rabab ahmed mohamed

Collaborators

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2016

Primary Completion (ACTUAL)

May 15, 2017

Study Completion (ACTUAL)

May 15, 2017

Study Registration Dates

First Submitted

January 14, 2019

First Submitted That Met QC Criteria

March 7, 2019

First Posted (ACTUAL)

March 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 12, 2019

Last Update Submitted That Met QC Criteria

March 8, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • beta-blockers and statins

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All medical history included medication and disease, in addition to our study outcomes

IPD Sharing Time Frame

IPD will be available from the time of publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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