Aggressive Hydration and Contrast-Induced Acute Kidney Injury Following Primary Angioplasty (ATTEMPT): A Prospective, Randomised , Open-Label Trial

Abstract

Background: Hydration remains the cornerstone prevention of contrast-induced acute kidney injury among high risk patients. However, there is great conflict between long-term preprocedural hydration and shortest door-to-balloon time among patients with ST-elevation myocardial infarction. We aimed to determine the effects of aggressive and targeted hydration on contrast-induced acute kidney injury in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. Methods: We did this open-label, randomized controlled trial at 15 teaching hospitals in China. Patients who undergoing primary percutaneous coronary intervention at high risk for contrast-induced acute kidney injury were randomized (1:1) to receive aggressive hydration (preprocedural loading dose of 125/250 mL normal saline within 30 minutes, followed by postprocedural hydration guided by left ventricular end-diastolic pressure for 4 hours and additional hydration until 24 hours after primary percutaneous coronary intervention) or general hydration (≤500 mL normal saline from randomization until 6 hours after primary percutaneous coronary intervention). The primary endpoint is contrast-induced acute kidney injury, defined as a >25% or 0.5 mg/dL increase in serum creatinine from baseline during the first 48-72 hours after primary angioplasty. Postprocedural acute heart failure is the safety endpoint. This trial is registered with ClinicalTrials.gov number, NCT02067195. Findings: Between July 2014 and May 2018, we enrolled 560 patients, of whom 488 patients (mean age 60.1 years, 414 [84.8%] male) were analysed after excluding 72 patients, and 19 patients were not included in primary endpoint analysis for lacking periprocedural serum creatinine data. Contrast-induced acute kidney injury occurred in 51 of 234 patients (21.8%) in the aggressive hydration group and 73 of 235 patients (31.1%) in the control group. The absolute difference (Aggressive hydration vs general hydration) was -11.9% (95% CI -9.4% to -15.0%). Postprocedural acute heart failure did not differ significantly between the aggressive hydration group and the control group (7.9% vs. 6.9%, P=0.69). Interpretation: In high-risk patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention, aggressive hydration reduced the risk of contrast-induced acute kidney injury and was generally well tolerated, with no significantly increase in postprocedural acute heart failure. Aggressive and targeted hydration could be a new treatment strategy for patients with ST-elevation myocardial infarction. Trial Registration Number: This trial is registered with ClinicalTrials.gov number, NCT02067195. Funding Information: National Science Foundation of China, Beijing Lisheng Cardiovascular Health Foundation and Guangdong Provincial People's Hospital Foundation. Declaration of Interests: Authors declared no competing interests. Ethical Approval: The study was approved by Guangdong Provincial People's Hospital institutional review board and regulatory authorities at sites not overseen by Guangdong Provincial People's Hospital.