Back to resultsComparison of Carvedilol and Atorvastatin for Preventing of Contrast-Induced Nephropathy. (CIN)
Primary Purpose
Contrast-induced Nephropathy
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Atorvastatin
Carvedilol
saline
Sponsored by
About this trial
This is an interventional prevention trial for Contrast-induced Nephropathy focused on measuring Cardiac catheterization, carvedilol, atorvastatin.
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group (A)
Group (B)
Group (C)
Arm 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.
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.
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
Outcomes
Primary Outcome Measures
development of contrast induced nephropathy
CIN :(defined as absolute rise in the baseline serum creatinine concentration by 0.5 mg/dL after 48 hours from CC).
Secondary Outcome Measures
Estimated Glomerular filtration rate (eGFR)
Cockcroft-Gault equation was used to calculate (eGFR)
Full Information
NCT ID
NCT03867994
First Posted
January 14, 2019
Last Updated
March 8, 2019
Sponsor
rabab ahmed mohamed
Collaborators
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT03867994
Brief Title
Comparison of Carvedilol and Atorvastatin for Preventing of Contrast-Induced Nephropathy.
Acronym
CIN
Official Title
Comparison of Carvedilol and Atorvastatin for Prevention of Contrast-Induced Nephropathy After Cardiac Catheterization
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
May 15, 2017 (Actual)
Study Completion Date
May 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
rabab ahmed mohamed
Collaborators
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast-induced Nephropathy
Keywords
Cardiac catheterization, carvedilol, atorvastatin.
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group (A)
Arm Type
Experimental
Arm 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.
Arm Title
Group (B)
Arm Type
Experimental
Arm 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.
Arm Title
Group (C)
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Intervention Type
Drug
Intervention Name(s)
saline
Other Intervention Name(s)
0.9%NaCl
Primary Outcome Measure Information:
Title
development of contrast induced nephropathy
Description
CIN :(defined as absolute rise in the baseline serum creatinine concentration by 0.5 mg/dL after 48 hours from CC).
Time Frame
1. Serum creatinine baseline was measured from venous blood (before initiating the hydration) and 48 hours after the CC procedure.
Secondary Outcome Measure Information:
Title
Estimated Glomerular filtration rate (eGFR)
Description
Cockcroft-Gault equation was used to calculate (eGFR)
Time Frame
on admission, and re-calculated 48 hours post CC using
Other Pre-specified Outcome Measures:
Title
Blood urea nitrogen (BUN)
Description
BUN was assayed using modified Urease-Berthelot Method (Egyptian company of biotechnology, Cairo. Egypt)
Time Frame
On admission, and re-calculated 48 hours post CC using
Title
Serum Neutrophil gelatinase - associated lipocalin (NGAL) Description: . NGAL was assayed by enzyme -linked immunosorbent assay ELISA (Glory Science Co., Ltd, CHINA).
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Comparison of Carvedilol and Atorvastatin for Preventing of Contrast-Induced Nephropathy.
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