Patients and methods
multiple myeloma, CM
MULTIPLE MYELOMA, HYPERSENSITIVITY, RHABDOMYOLYSIS, LIVER DISEASE
This 4-day, randomized, placebo-controlled, parallel-group, registered clinical trial (ClinicalTrials.gov identifier NCT03391830) was conducted between January 2018 and January 2020 at tertiary urology center outpatients clinic for patients with serum creatinine ≤ 1.4 mg/dl, underwent elective contrast-enhanced computed tomography (CECT). The study protocol was approved by Institutional Review Boards (R/17.06.05). Fully informed consent was obtained from all patients, in line with Good Clinical Practice and the Declaration of Helsinki.Eligible patients were statin naïve patients, or not on statin treatment for at two weeks planned for CECT. Patients with history of liver disease, rhabdomyolysis, contrast hypersensitivity, and multiple myeloma were excluded. None of the patients received metformin, nonsteroidal anti-inflammatory drugs, theophylline, Patients were randomized allocated to two groups: the first group received Lipitor (atorvastatin—Pfizer Egypt, under Authority of: Pfizer INC., USA) 80-mg the day before the study and atorvastatin 40-mg two hours before the CECT and for continue on atorvastatin 40-mg two days after CECT; plus C-Retard 500 mg (ascorbic acid—Hikma Pharma, October City, Egypt) with atorvastatin. The other group received two tablets of placebo once/daily before the procedure and for another 3 days.The primary outcome was to assess the incidence of PC-AKI in both groups, defined as The KDIGO criteria [Normal saline (0.9 percent) was given intravenously at a rate of 1 ml per kilogram of body weight per hour for 12 h before and 12 h after administration of the contrast agent. All patients were encouraged to drink if they were thirsty. The dose of nonionic, low-osmolality CM (Iopromide; Ultravist-300, Schering, Berlin, Germany) was 75 ml for all patients. Serum creatinine was measured immediately before administration of the CM, and 73 h after, and one week in case of increase serum creatinine post CECT.A per-protocol analysis is performed and includes all randomized patients who are compliant to treatment and complete their follow up. The null hypothesis assumed there is no difference between ascorbic acid and statin arm and placebo on the effect on PC-AKI.The power of the study was calculated using the G*Power program (University of Düsseldorf, Düsseldorf, Germany) to determine an adequate sample size based on previous trial assuming a maximum serum creatinine differences in the statin and placebo groups [Statistical analysis was performed using the IBM Statistical Package for the Social Sciences (SPSS®), version 22.0 for Windows (IBM Corp., Armonk, NY, USA). Qualitative data are described as numbers (percentages). Quantitative data are described as median (interquartile range). For the normally distributed variables, the independent sample 