Contrast-Induced Acute Kidney Injury in Acute Heart Failure With Renal Dysfunction: The Kidney Protection Strategies Evaluation in Acute Heart Failure (K-PROSE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Jin Joo Park
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Incidence of contrast-induced acute kidney injury
研究概览
简要总结
The K-PROSE study is a randomized clinical investigation evaluating strategies to prevent contrast-induced acute kidney injury (CI-AKI) in patients hospitalized with acute heart failure and moderate renal dysfunction (eGFR 30-75 mL/min/1.73 m²). Patients requiring contrast-enhanced CT imaging are randomized to either standard intravenous saline hydration or a furosemide-based decongestion strategy. Renal function is assessed using serial measurements of creatinine and cystatin C, before and after contrast exposure. By comparing renal outcomes, congestion status, and safety profiles, this study aims to determine whether a decongestion-focused approach provides superior renal protection compared with conventional hydration in high-risk acute heart failure patients.
详细描述
Patients hospitalized with acute heart failure frequently require contrast-enhanced computed tomography or coronary imaging to identify precipitating etiologies and guide management. However, many of these patients have concomitant renal dysfunction, and exposure to iodinated contrast media places them at high risk for contrast-associated acute kidney injury (CA-AKI). Conventional prevention strategies rely on periprocedural intravenous isotonic saline hydration, which may be inappropriate or harmful in the setting of acute heart failure due to the risk of worsening congestion and pulmonary edema. Consequently, optimal renal protection strategies for this vulnerable population remain uncertain.
The Kidney Protection Strategies Evaluation in Acute Heart Failure (K-PROSE) study is a prospective, randomized clinical study designed to compare two renal protection strategies in patients hospitalized with acute heart failure and moderate renal dysfunction who are scheduled to undergo contrast-enhanced computed tomography. Eligible patients are randomly assigned to receive either standard intravenous isotonic saline hydration or a furosemide-based decongestion strategy prior to and following contrast exposure. The study is designed to reflect real-world clinical practice while systematically evaluating renal and congestion-related outcomes.
Renal function is assessed using serial measurements of serum creatinine and estimated glomerular filtration rate, along with emerging biomarkers of kidney injury, including cystatin C and neutrophil gelatinase-associated lipocalin (NGAL). These biomarkers are incorporated to enable early and sensitive detection of renal injury beyond conventional creatinine-based definitions. Urine chemistry parameters, including fractional excretion of sodium, are also collected to characterize renal physiology and treatment response.
In parallel, markers of volume status and heart failure severity-including daily body weight, urine output, physical examination findings, chest radiography, and natriuretic peptide levels-are prospectively recorded to evaluate the effects of each strategy on congestion and hemodynamic stability. Safety assessments include monitoring for electrolyte abnormalities, hypotension, worsening heart failure, and other adverse events throughout the study period.
By directly comparing a conventional hydration-based approach with a decongestion-focused strategy in a high-risk acute heart failure population, the K-PROSE study aims to clarify whether renal protection can be achieved without exacerbating congestion. The findings are expected to provide clinically relevant evidence to guide contrast-related decision-making and renal protection strategies in patients with acute heart failure and impaired kidney function.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 20 years or older
- •Emergency department visit/hospitalization for acute heart failure with clinical evidence of congestion
- •Planned contrast-enhanced computed tomography during the index hospitalization
- •Baseline renal dysfunction defined as an estimated glomerular filtration rate (eGFR) of 30-75 mL/min/1.73 m²
排除标准
- •Requirement for vasopressor therapy
- •Requirement for renal replacement therapy (dialysis)
- •Known allergy or hypersensitivity to furosemide
- •Ongoing acute coronary syndrome
- •Pregnant or breastfeeding women, or women of childbearing potential without a negative pregnancy test
- •Hyperkalemia (serum potassium >5.5 mmol/L)
- •Uncorrected volume depletion or hyponatremia (serum sodium <130 mmol/L)
- •Any condition deemed by the investigator to make participation in the study inappropriate
研究组 & 干预措施
Furosemide-Based Decongestion Strategy
Participants receive intravenous furosemide to achieve sufficient diuresis (target ≥1,000 mL) as a decongestion-based strategy for renal protection before contrast-enhanced computed tomography.
干预措施: Furosemide (Drug)
Standard Intravenous Saline Hydration
Participants receive standard intravenous hydration with 0.9% normal saline (1ml/kg) before and after contrast-enhanced computed tomography as a conventional strategy for the prevention of contrast-induced acute kidney injury.
干预措施: 0.9 % Normal Saline (Drug)
结局指标
主要结局
Incidence of contrast-induced acute kidney injury
时间窗: baseline and at 48 hours
Contrast-induced acute kidney injury is defined as an increase in serum creatinine or cystatin C of ≥0.3 mg/dL or ≥25% from baseline within 48 hours after contrast-enhanced computed tomography.
Incidence of contrast-associated acute kidney injury
时间窗: at 48 hours
Incidence of contrast-associated acute kidney injury, defined as an increase in serum creatinine of ≥0.3 mg/dL from baseline or to ≥1.5 times the baseline value within 48 hours after contrast exposure
次要结局
- Change in serum cystatin C level(Baseline and at 48 hours)
- Change in body weight(Baseline, up to 7 days)
- All-cause mortality(Baseline, day 90)
- Length of stay(Baseline, day 90)
- ICU admission(Baseline, day 90)
- Worsening heart failure(At day 90)
- Change of other laboratory parameters(Baseline and at day 7)
- Change of other laboratory parameters(Baseline and at 48 hours)
- Acute kidney injury(48 hours)
- serum creatinine and eGFR(baseline through day 7)
- Change of NGAL(Baseline and at 24 and 48 hours)
- Change of NT-proBNP(Baseline and at day 7)
- Renal replacement therapy(day 90)
研究者
Jin Joo Park
Professor
Seoul National University Bundang Hospital