A Phase 2 interventional study of Atorvastatin and Carvedilol in Contrast-induced Nephropathy, sponsored by rabab ahmed mohamed. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-03-12.
Sponsored by rabab ahmed mohamed · Phase 2, Interventional, and Prevention
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.
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 144 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →This is the only study on the registry with rabab ahmed mohamed as lead sponsor.
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Exclusion Criteria:
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
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
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
Also known as: 0.9%NaCl
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).
Time frame: 1. Serum creatinine baseline was measured from venous blood (before initiating the hydration) and 48 hours after the CC procedure.
Estimated Glomerular filtration rate (eGFR)
Cockcroft-Gault equation was used to calculate (eGFR)
Time frame: on admission, and re-calculated 48 hours post CC using
Blood urea nitrogen (BUN)
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
Serum Neutrophil gelatinase - associated lipocalin (NGAL) Description: . NGAL was assayed by enzyme -linked immunosorbent assay ELISA (Glory Science Co., Ltd, CHINA).
. 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.
No study locations are listed for this record.
Plan to share: Yes — All medical history included medication and disease, in addition to our study outcomes
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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