Evaluation of the preventive effect of intravenous trans-sodium crocetinate followed by oral crocetin on contrast-induced nephropathy in patients with chronic kidney disease undergoing coronary angioplasty: A randomized placebo-controlled triple-blind clinical trial

Objective: Contrast media (CM) can potentially cause nephropathy. Trans-sodium crocetinate (TSC) has shown promising antioxidant and anti-inflammatory properties in animal studies. This research sought to assess TSC efficacy in contrast-induced nephropathy (CIN) prevention.Materials and Methods: A randomized triple-blind trial involving ۱۳۰ patients undergoing elective PCI (percutaneous coronary intervention) was conducted. Participants received either TSC (۰.۵ mg/kg) before the procedure, followed by crocetin tablets thrice daily for five days to evaluate its impact on CIN occurrence, or a placebo. The primary outcome was the occurrence of CIN, with secondary outcomes including blood urea nitrogen (BUN), serum creatinine (SCr), glomerular filtration rate (GFR), C-reactive protein (CRP), urine albumin-to-creatinine ratio (ACR), and prooxidant-antioxidant balance (PAB) test in a ۵-day follow-up.Results: The study's primary outcome revealed a significantly lower CIN prevalence in the TSC group (۷.۷%) compared to the placebo group (۲۴.۶%) (p = ۰.۰۰۹). Secondary outcomes showing significant inter-group differences included BUN (p<۰.۰۰۱), GFR (p<۰.۰۵), CRP (p<۰.۰۰۱), ACR (p<۰.۰۵), and PAB test (p<۰.۰۵). However, SCr and adverse effects did not differ significantly between the groups.Conclusion: TSC demonstrated its ability to impede nephrotoxic processes and significantly reduce CIN incidence. Additional clinical studies are required to further validate the beneficial effects in this context.

Keywords:

Saffron Trans sodium crocetinate Percutaneous coronary intervention Contrast , induced nephropathy