The prevention of contrast induced nephropathy by sarpogrelate in patients with chronic kidney disease: a study protocol for a prospective randomized controlled clinical trial

Park, Kyungil; Chung, Woo-Young; Seo, Jae Bin; Kim, Sang-Hyun; Zo, Joo Hee; Kim, Myung‐A; Park, Young Bae

doi:10.1186/1745-6215-11-122

Cited by 7 publications

(6 citation statements)

References 27 publications

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“…Presumed mechanisms include contrast‐induced vasoconstriction of renal vasculature, decreased oxygenation of the medulla, direct cellular damage by reactive oxygen species resulting in ATN, and decreased glomerular filtration due to interference with tubuloglomerular feedback systems, which have prompted use of the aforementioned interventions . Despite widespread use of volume expansion, and interventions used independently or in addition to fluid administration including N‐acetylcysteine, sodium bicarbonate, theophylline, and other options including nonionic contrast, CIN continues to occur at a significant rate …”

Section: Discussionmentioning

confidence: 99%

“…Various pharmacologic and therapeutic interventions have been employed to counteract hypoxia and decreased renal perfusion, with little demonstrated benefit in the prevention of CIN or small pooled effects. These methods include alkalinization of renal tubules with sodium bicarbonate, use of antioxidants such as N‐acetylcysteine or sodium 2‐mercaptoethanesulfonate, adenosine antagonists, hemofiltration, use of iso‐osmolar contrast agents, and current investigation into use of sarpogrelate, a 5HT2 platelet‐receptor blocker with no published clinical trials to date . The standard of care consists of volume expansion with isotonic saline.…”

Section: Introductionmentioning

confidence: 99%

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A Review of the Use of Iloprost, A Synthetic Prostacyclin, in the Prevention of Radiocontrast Nephropathy in Patients Undergoing Coronary Angiography and Intervention

Kassis

Minsinger

McCullough³

et al. 2015

Clinical Cardiology

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Iloprost, a prostacyclin analogue, has been effective in preventing renal dysfunction among transplant patients. We hypothesized that iloprost is protective against renal dysfunction in different settings, in which similar underlying mechanisms of nephrotoxicity occur. We conducted a literature review, and discuss the application of iloprost in reducing acute renal insufficiency and the pathophysiological mechanisms of contrast-induced nephropathy (CIN). One proposed mechanism of CIN is prolonged renal arterial vasoconstriction, causing renal hypoperfusion, ischemia, and release of free radicals. Iloprost is an analogue of the vasodilatory prostaglandin PGI 2 . It has demonstrated cytoprotective properties in the renal transplant population by inhibiting lysosomal degradation and release of free radicals, allowing membrane stabilization. Two good-quality studies reported on iloprost and CIN. Five studies reported protective effects of iloprost in renal transplantation and 1 in coronary artery bypass grafting. Iloprost was found to be renoprotective in patients with baseline renal insufficiency who underwent coronary angiography for CIN (risk ratio [RR] = 0.32, 95% confidence interval [CI]: 0.16-0.67) and increases the weighted mean difference improvement in creatinine clearance (RR = 4.56, 95% CI: 1.82-7.30). CIN is associated with major adverse cardiac events. Preventing CIN is important for patient safety and reducing disease burden. Iloprost may reduce CIN by up to 68%. The same mechanisms of iloprost that inhibit graft dysfunction in the acute post-renal transplant and cardiopulmonary bypass setting may also contribute to preventing CIN. Large randomized controlled trials are necessary to determine the clinical efficacy of iloprost in the angiography setting. IntroductionContrast-induced nephropathy (CIN), defined as >0.5 mg/dL increase or relative increase >25% of baseline creatinine approximately 48 to 72 hours after the administration of contrast, is expected to increase in incidence proportionally with the expected increase in cardiac interventions necessary in an aging population. Risk factors include preexisting renal insufficiency, diabetic nephropathy, age

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A Review of the Use of Iloprost, A Synthetic Prostacyclin, in the Prevention of Radiocontrast Nephropathy in Patients Undergoing Coronary Angiography and Intervention

Kassis

Minsinger

McCullough³

et al. 2015

Clinical Cardiology

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“…The study design was previously published 15. The study was designed as a non-blinded, prospective, randomized controlled clinical trial in a single center to evaluate the efficacy and safety of sarpogrelate with respect to CIN in chronic kidney disease (CKD) patients undergoing diagnostic coronary angiography (CAG) or percutaneous coronary intervention (PCI).…”

Section: Methodsmentioning

confidence: 99%

The Prevention of Contrast Induced Nephropathy by Sarpogrelate: a Prospective Randomized Controlled Clinical Trial

Kwon

Kim

et al. 2019

J Korean Med Sci

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BackgroundAlthough some strategies are used for prophylaxis of contrast induced nephropathy, their efficacy is not fully established. Sarpogrelate can relieve vasospasm and have anti-inflammatory action. This study examined whether sarpogrelate reduces the incidence of contrast induced nephropathy (CIN) or subsequent renal impairment during four weeks after coronary angiography compared with a control group.MethodsSeventy-four participants with chronic renal failure were randomly assigned to the sarpogrelate or control group. Patients assigned to the sarpogrelate group received oral saporogelate from 24 hours before contrast exposure up to one month after contrast exposure. The primary outcome of this study was the incidence of CIN within 48 hours after exposure to the contrast agent.ResultsThirty-one subjects in the control group and 35 subjects in the sarpogrelate group were used for the analysis. Cumulative CIN occurred numerically more at 48 hours in the sarpogrelate group and less at one month without statistical significance (11.4% vs. 6.5% at 48 hours and 11.4% vs. 16.1% at one month, respectively). Baseline renal function was similar in both groups, but the estimated glomerular filtration rate (eGFR) was lower in the sarpogrelate group at 12 and 48 hours compared with the control group (45.6 vs. 54.7 mL/min/1.73m2; P = 0.023 and 39.9 vs. 50.6 mL/min/1.73m2; P = 0.020, respectively). At one month, the eGFR became comparable between the two groups because the eGFR was aggravated in the control group and maintained in the sarpogrelate group.ConclusionThis study failed to demonstrate that sarpogrelate has a renoprotective effect against contrast induced acute kidney injury.Trial RegistrationClinicalTrials.gov Identifier: NCT01165567

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“…Compared with men, women have increased cardiovascular mortality, especially after menopause (14). Specifically, in-hospital mortality after coronary angiography is higher in women (15,16), although in these cohorts, women were older and had a greater burden of comorbidity than men (17)(18)(19). CIAKI may be a factor in the relatively detrimental hospital course observed in women, although the reason for the higher incidence of CIAKI in women is unknown.…”

Section: Discussionmentioning

confidence: 99%

Short-term rosuvastatin therapy prevents contrast-induced acute kidney injury in female patients with diabetes and chronic kidney disease: a subgroup analysis of the TRACK-D study

Li¹,

Li²,

Xu³

et al. 2016

J. Thorac. Dis.

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Background: Female patients are at higher risk of contrast-induced acute kidney injury (CIAKI) compared to males. In the multicenter, prospective, TRACK-D study, short-term rosuvastatin has proven effectively reduce CIAKI in patients with type 2 diabetes mellitus and stage 2-3 chronic kidney disease (CKD). This study aimed to explore the efficacy of rosuvastatin in the female TRACK-D population.Methods: This study was a gender-based analysis of 2,998 patients (1,044 females) enrolled in the TRACK-D study and were randomized to short-term (2 days before and 3 days after procedure) rosuvastatin therapy or standard of care. The primary outcome was the incidence of CIAKI and the secondary outcome was a composite of death, dialysis/hemofiltration or worsening heart failure at 30 days.Results: CIAKI incidence was comparable between male and female patients in the overall study population (2.5% vs. 3.4%, P=0.165) and in the rosuvastatin group (2.4% vs. 2.1%, P=0.72), while it was higher in females than in males in the control group (3.1% vs. 5.3%, P=0.04). Female gender was an independent risk factor of CIAKI [odds ratio (OR) =1.65; 95% confidence interval (CI), 1.03-2.63; P=0.036].Rosuvastatin treatment vs. control lowered CIAKI rate in females [2.1% vs. 5.3%; relative risk (RR) =0.39; 95% CI, 0.19-0.77; number needed to treat (NNT) =31], particularly among those with CKD stage 2 (1.2% vs. 4.1%, P=0.011). Secondary outcome incidence was similar for females in the rosuvastatin and control groups (3.7% vs. 4.9%, P=0.37). Conclusions: Compared to males, untreated females with diabetes mellitus and CKD had a higher risk of CIAKI, which can be reduced by short-term rosuvastatin treatment.

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The prevention of contrast induced nephropathy by sarpogrelate in patients with chronic kidney disease: a study protocol for a prospective randomized controlled clinical trial

Cited by 7 publications

References 27 publications

A Review of the Use of Iloprost, A Synthetic Prostacyclin, in the Prevention of Radiocontrast Nephropathy in Patients Undergoing Coronary Angiography and Intervention

A Review of the Use of Iloprost, A Synthetic Prostacyclin, in the Prevention of Radiocontrast Nephropathy in Patients Undergoing Coronary Angiography and Intervention

The Prevention of Contrast Induced Nephropathy by Sarpogrelate: a Prospective Randomized Controlled Clinical Trial

Short-term rosuvastatin therapy prevents contrast-induced acute kidney injury in female patients with diabetes and chronic kidney disease: a subgroup analysis of the TRACK-D study

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