title: Aggressive hydraTion in patients with ST-Elevation Myocardial infarction undergoing Primary percutaneous coronary intervention to prevenT contrast-induced nephropathy (ATTEMPT): Study design and protocol for the randomized, controlled trial, the ATTEMPT, RESCIND 1 (First study for REduction of contraSt-induCed nephropathy followINg carDiac catheterization) trial.
abstract: Adequate hydration is recommended for acute ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) to prevent contrast-induced nephropathy (CIN). However, the optimal hydration regimen has not been well established in these high-risk patients. The objective of this study is to evaluate the efficacy of a preprocedural loading dose plus postprocedural aggressive hydration with normal saline guided by the left ventricular end-diastolic pressure (LVEDP) compared with general hydration for CIN prevention. The ATTEMPT study is a multicenter, open-label, investigator-driven, randomized controlled trial in China. Approximately 560 patients with STEMI undergoing primary PCI will be randomized (1:1) to receive either periprocedural general hydration (control group) or aggressive hydration (treatment group). Patients in the control group receive periprocedural general hydration with ≤500 mL normal saline (within 6 hours) at a normal rate (0.5 or 1 mL/kg · h). Patients in the treatment group receive a preprocedural loading dose (125/250 mL) of normal saline within 30 minutes and intravenous hydration at a normal rate until LVEDP is available, followed by postprocedural aggressive hydration guided by LVEDP for 4 hours and then continuous intravascular hydration at the normal rate until 24 hours after PCI. The primary end point is CIN, defined as a >25% or 0.5-mg/dL increase in serum creatinine from baseline during the first 48 to 72 hours after procedure. The ATTEMPT study has the potential to identify optimal hydration regimens for STEMI patients undergoing PCI.
authors: Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial Key Laboratory of Coronary Disease, Guangdong General Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, Guangzhou, China.
authors: Yong
authors: Y
authors: Liu
authors: Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial Key Laboratory of Coronary Disease, Guangdong General Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, Guangzhou, China. Electronic address: chenjiyandr@126.com.
authors: Ji-Yan
authors: JY
authors: Chen
authors: Department of Cardiology, Peking University First Hospital, Beijing, China.
authors: Yong
authors: Y
authors: Huo
authors: Department of Cardiology, Zhongshan Hospital Affiliated to Fudan University, Shanghai, China.
authors: Jun-Bo
authors: JB
authors: Ge
authors: Duke Clinical Research Institute, Durham, NC.
authors: Ying
authors: Y
authors: Xian
authors: National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Department of Biostatistics, School of Public Health and Tropical Medicine, Southern Medical University, Guangzhou, China.
authors: Chong-Yang
authors: CY
authors: Duan
authors: Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial Key Laboratory of Coronary Disease, Guangdong General Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, Guangzhou, China; National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Department of Biostatistics, School of Public Health and Tropical Medicine, Southern Medical University, Guangzhou, China; Department of Biostatistics, South China College of Cardiovascular Research, Guangdong Society of Interventional Cardiology, Guangzhou, China.
authors: Shi-Qun
authors: SQ
authors: Chen
authors: Duke Clinical Research Institute, Durham, NC.
authors: Wei
authors: W
authors: Jiang
authors: National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research, Department of Biostatistics, School of Public Health and Tropical Medicine, Southern Medical University, Guangzhou, China.
authors: Ping-Yan
authors: PY
authors: Chen
authors: Department of Cardiology, Guangdong Cardiovascular Institute, Guangdong Provincial Key Laboratory of Coronary Disease, Guangdong General Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, Guangzhou, China.
authors: Ning
authors: N
authors: Tan
mesh_terms: D058186:Acute Kidney Injury / Q000139:chemically induced / Q000517:prevention & control*; D002681:China / Q000453:epidemiology; D003287:Contrast Media / Q000009:adverse effects*; D017023:Coronary Angiography / Q000009:adverse effects* / Q000379:methods; D004562:Electrocardiography; D005260:Female; D005440:Fluid Therapy / Q000379:methods*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging / Q000628:therapy*; D062645:Percutaneous Coronary Intervention; D011300:Preoperative Care / Q000379:methods*; D011446:Prospective Studies; D012107:Research Design; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D003287:Contrast Media