The Effect of Hydration on the Prevention of Contrast Induced Acute Kidney Injury (CI-AKI) in ST Segment Elevation Myocardial Infarction Undergoing Primary PCI (Hydro-AKI Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 384
- 主要终点
- Incidence of contrast-induced acute kidney injury (CI-AKI)
研究概览
简要总结
The goal of this clinical trial is to determine whether a structured oral hydration regimen reduces the incidence of contrast-induced acute kidney injury (CI-AKI) in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI). The main questions it aims to answer are:
Does a structured oral hydration regimen reduce the incidence of CI-AKI compared with standard care without a prescribed hydration regimen? Does oral hydration improve renal outcomes without increasing the risk of adverse events, such as heart failure or fluid overload, in patients undergoing PPCI?
Researchers will compare patients receiving a structured oral hydration regimen with patients receiving standard care without a prescribed hydration regimen to determine whether oral hydration decreases the incidence of CI-AKI and improves clinical outcomes.
Participants will:
Be randomly assigned to either the oral hydration group or the standard care group.
Undergo primary percutaneous coronary intervention according to institutional practice.
Receive the assigned hydration strategy after the procedure. Have serum creatinine measured at baseline and after contrast exposure to assess for CI-AKI.
Be monitored for adverse events, including fluid overload, heart failure, need for renal replacement therapy, length of hospital stay, and other relevant clinical outcomes.
详细描述
Contrast-induced acute kidney injury (CI-AKI) remains one of the most common complications following primary percutaneous coronary intervention (PPCI) in patients presenting with ST-segment elevation myocardial infarction (STEMI). The development of CI-AKI is associated with prolonged hospitalization, increased healthcare costs, higher rates of cardiovascular complications, and increased short- and long-term mortality. Despite advances in interventional cardiology, effective preventive strategies for CI-AKI in the emergency PPCI setting remain limited.
Adequate hydration is considered the cornerstone of CI-AKI prevention because it improves renal perfusion, suppresses vasoconstrictive mechanisms, dilutes intratubular contrast media, and promotes urinary excretion of contrast agents. However, the evidence supporting hydration strategies has been derived primarily from elective coronary procedures, where patients can receive intravenous hydration before and after contrast administration. In STEMI patients undergoing PPCI, the urgent nature of treatment often precludes pre-procedural hydration, and aggressive intravenous fluid administration may increase the risk of volume overload in patients with impaired cardiac function.
Oral hydration represents a simple, inexpensive, and widely accessible alternative that may offer renal protection while minimizing the logistical challenges associated with intravenous hydration in the acute setting. However, evidence regarding its effectiveness in patients undergoing emergency PPCI remains scarce, particularly in low- and middle-income countries.
This prospective, randomized, controlled clinical trial is designed to evaluate whether a structured oral hydration regimen initiated after PPCI reduces the incidence of CI-AKI compared with standard care without a prescribed hydration regimen. Eligible adult patients presenting with STEMI and undergoing successful PPCI will be randomly assigned in a 1:1 ratio to receive either the oral hydration protocol or standard care. All participants will receive routine evidence-based management for STEMI according to current institutional practice and contemporary clinical guidelines.
Renal function will be assessed using serum creatinine measurements obtained at baseline and after contrast exposure. CI-AKI will be defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Participants will also be monitored for safety outcomes, including signs and symptoms of heart failure or fluid overload, as well as clinically relevant in-hospital outcomes. Additional analyses will evaluate the relationship between oral hydration adherence and renal outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •All of the following must be present:
- •Age ≥18 years at the time of randomization
- •Clinical diagnosis of STEMI, confirmed by 12-lead ECG showing ≥30 minutes of ST-segment elevation ≥1 mm in ≥2 contiguous limb leads or ≥2 mm in ≥2 contiguous precordial leads, or new left bundle branch block with a clinical presentation consistent with acute myocardial infarction
- •Decision to proceed with primary PCI as the reperfusion strategy, within 12 hours of symptom onset (or up to 24 hours if evidence of persistent ischaemia or haemodynamic instability)
- •Estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m², calculated by the CKD-EPI 2021 formula from the most recent available serum creatinine measurement prior to contrast exposure
- •Ability to swallow and safely tolerate oral fluids, as assessed by the attending physician
- •Oral informed consent obtained from the patient or a legally authorized representative (deferred consent protocol applies in emergencies per IRB approval)
排除标准
- •- Cardiogenic shock on presentation, defined as systolic blood pressure <90 mmHg for >30 minutes despite fluid resuscitation, or requirement for vasopressor or inotropic therapy to maintain SBP ≥90 mmHg, with evidence of end-organ hypoperfusion (Killip Class IV)
- •Acute pulmonary oedema or Killip Class III with SpO₂ <90% on room air, bilateral crepitations >50% of lung fields, or chest X-ray showing pulmonary venous congestion requiring urgent diuresis
- •Pre-existing dialysis dependence (haemodialysis or peritoneal dialysis) or eGFR <30 mL/min/1.73m² on admission
- •Active vomiting, dysphagia, altered consciousness (GCS <14), or any clinical condition precluding safe oral fluid intake, as assessed by the attending physician
- •Administration of any IV hydration protocol for CIN prevention prior to randomization (patients may have received standard IV fluids for other indications; these are documented but do not constitute exclusion unless specifically intended as CIN prophylaxis)
- •Known severe allergy to iodinated contrast media that cannot be managed with pre-medication (moderate/mild allergies and prior mild reactions are not exclusions)
- •Concurrent administration of known nephrotoxic agents within 48 hours that cannot be withheld or dose-adjusted: aminoglycoside antibiotics (gentamicin, amikacin), high-dose loop diuretics in the context of diuretic nephropathy, or cisplatin-based chemotherapy
- •Pregnancy (confirmed by urine or serum beta-hCG) or active breastfeeding
- •Estimated life expectancy <30 days from a non-cardiac cause (advanced malignancy, end-stage liver disease, multiorgan failure)
研究组 & 干预措施
Structured Oral Hydration , Arm 1
Participants randomized to the intervention arm will receive a structured oral hydration regimen in addition to standard medical care. The protocol consists of a target oral fluid intake of at least 1,500 mL within 12 hours of primary percutaneous coronary intervention (PPCI), including 500 mL of plain water 30-60 minutes before arterial sheath insertion, 500 mL of water within the first 4 hours after sheath removal, and at least 500 mL of water during 4-12 hours after the procedure. Oral fluid intake will be encouraged by nursing staff, documented on a standardized fluid intake chart, and reviewed by the research coordinator at the 12-hour time point. Participants will otherwise receive standard guideline-directed care for STEMI.
干预措施: oral hydration protocol (Other)
Standard Care / No Prescribed Oral Hydration Regimen (control arm)
Participants randomized to the control arm will receive standard medical care for ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI) according to institutional practice. No structured oral hydration regimen will be prescribed. Oral fluid intake will be permitted according to routine clinical care and at the discretion of the treating healthcare team. All other aspects of patient management, including medications, monitoring, and follow-up, will be provided in accordance with current institutional protocols and clinical guidelines.
结局指标
主要结局
Incidence of contrast-induced acute kidney injury (CI-AKI)
时间窗: Within 48 hours after primary percutaneous coronary intervention (PPCI)
Incidence of CI-AKI, defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria as an increase in serum creatinine of ≥0.3 mg/dL within 48 hours or ≥1.5 times baseline within 7 days after contrast exposure.
次要结局
未报告次要终点
研究者
Alaa Khaled Mohamed
principle investigator
Assiut University