Efficacy of post-procedural oral hydration volume on risk of contrast-induced acute kidney injury following primary percutaneous coronary intervention: Study protocol for a randomized controlled trial

Abstract

Background: Contrast-induced acute kidney injury (CI-AKI) contributes toward unfavorable clinical outcomes. Oral hydration with water is inexpensive and it may be effective in the prevention of CI-AKI, but its efficacy among patients undergoing primary percutaneous coronary intervention (PCI) remains unknown. Methods/design: Our study is a secondary analysis on the database from the ATTEMPT study. We enrolled ST-elevation myocardial infarction (STEMI) patients undergoing primary PCI. Eligible patients received peri-procedural aggressive (left ventricular end-diastolic pressure-guided) or routine (≤ 500 mL) intravenous hydration with an isotonic solution (0.9% NaCl) with randomization. The primary endpoint was CI-AKI, defined as a > 25% or 0.5 mg/dL increase in serum creatinine from baseline during the first 48-72 h post-procedurally. All patients drank unrestricted amounts of fluids freely, the volume of which was recorded until 24 h following primary PCI. Oral hydration volume/weight (OHV/W) ratios were calculated. The association between post-procedural oral hydration (quartiles) and CI-AKI was assessed using multivariable analysis controlling for confounders, including intravenous hydration strategies. Discussion: Our study determined the effects of post-procedural oral hydration on CI-AKI following primary PCI, which is a potential strategy for CI-AKI prevention among patients with STEMI at very high risk. Trial registration: ClinicalTrials.gov, NCT02067195. Registered on 21 February 2014.