Oral prostaglandin e1 in combination with sodium bicarbonate and normal saline in the prevention of contrast-induced nephropathy: a pilot study.

The purpose of this study was to evaluate the use of prostaglandin E1 (PGE1) as a renal protective medication for patients exposed to contrast agents, as well as to demonstrate the safety, efficacy, and low side-effect profile of PGE1. A prospective, randomized, double-blind study was designed to compare combination of intravenous sodium bicarbonate, normal saline, and oral PGE1 200 μg versus the combination and placebo for renal protection from contrast agents. All patients receiving nonionic contrast during their interventional procedure were eligible for enrollment. Creatinine levels were recorded before and after the administration of contrast and renal protective medications. Contrast-induced nephrotoxicity (CIN) was defined as an increase of 0.5 mg/dL or greater in creatinine level, or an increase of 25% or more above baseline. Age, gender, total amount of contrast used, and incidence of renal failure requiring dialysis were recorded. We conducted the study on 41 patients. Of these, 20 patients received PGE1 and 21 received the placebo. The study group comprised 29 males and 12 females. Diabetes mellitus occurred in 41.5% of the cases (including 40% of PGE1 and 43% of placebo patients). Average contrast use was 77.2 mL (range, 15 to 200 mL). Mean age of the groups was 67.2 years. Average baseline creatinine level was 1.17. The differences between the groups were not statistically significant. CIN by definition occurred in one patient, who received the placebo. Incidence of new onset renal failure requiring dialysis was zero. Postcontrast change in creatinine level for the study was 0.11. There was a change in the creatinine level of 0.161 in the PGE1 group and 0.061 in the placebo group; an improvement of 0.10. PGE1 was not effective in significantly altering postcreatinine levels (p = 0.176). None of the patients enrolled in the study suffered any side effects from taking the PGE1 tablet. Although preliminary, this study shows that the addition of PGE1 for the prevention of CIN is well-tolerated by patients and is a safe modality. Additional studies are required to evaluate efficacy.

RCT Entities:   Population Interventions Outcomes