Body Composition, Kidney Size, and Medication Dosing in Patients With Acute Kidney Injury: A Telephone-Based Follow-Up Study at 90 Days and 12 Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Proportion of Participants Surviving at 90 Days
研究概览
简要总结
Acute Kidney Injury (AKI) is a common and serious condition affecting up to 12% of hospitalized patients, with increasing severity linked to higher mortality. Despite early detection via automated warning systems, clinical outcomes such as hospital length of stay, dialysis need, and death remain suboptimal. This non-interventional study evaluates modifiable factors influencing AKI outcomes by integrating four key components: body composition, kidney size, medication dosing, and patient-reported outcomes. Body composition is assessed using non-invasive bioimpedance spectroscopy to evaluate fluid status, muscle mass, and fat mass. Kidney size and structure are assessed via point-of-care ultrasound to detect underlying chronic kidney disease or obstructive causes. A standardized national medication plan is used to review drug dosing, interactions, and potential errors, supported by nephrology and pharmacy expertise. Additionally, patients are contacted by telephone at 90 and 365 days post-diagnosis to assess awareness of AKI, perceived severity, health literacy, and current kidney function (via blood tests and medication review). The study evaluates whether early, multidimensional assessment is associated with improved patient understanding, care coordination, and long-term outcomes. Findings may inform future strategies to enhance AKI management, reduce complications, and improve patient-centered care.
详细描述
Acute kidney injury (AKI) is a common and serious condition affecting up to 12% of hospitalized patients, with mortality increasing significantly with severity. Despite the implementation of automated AKI alert systems, clinical outcomes such as hospital length of stay, dialysis need, and death remain suboptimal. This non-interventional, single-center study aims to improve understanding of modifiable factors influencing AKI outcomes by integrating four key components: body composition, kidney size, medication dosing, and patient-reported outcomes.
The primary objective is to assess the prevalence of fluid imbalance, structural kidney abnormalities, and medication errors in patients with AKI Stage 3. It is hypothesized that most patients with AKI are not in a state of euvolemia (i.e., they have either fluid overload or dehydration), that pre-existing chronic kidney disease is detectable via abnormal kidney sonography, and that a significant proportion of patients have medication dosing errors, including inappropriate, contraindicated, or nephrotoxic drugs.
Secondary objectives include evaluating patient awareness of AKI diagnosis, assessing whether patients receive follow-up kidney function monitoring within 90 days after hospital discharge, and identifying gaps in post-discharge care. It is hypothesized that fewer than 100% of patients are aware of their AKI diagnosis, and that a substantial proportion do not undergo follow-up kidney function testing within 90 days.
The study population includes adult patients (≥18 years) with a confirmed diagnosis of AKI Stage 3, defined by an increase in serum creatinine ≥3-fold from baseline or ≥4 mg/dL with an acute rise of ≥0.5 mg/dL, or oliguria (<0.5 mL/kg/h for >6 hours). Patients are identified via the hospital's automated AKI alert system and approached by the nephrology consultative service during hospitalization. Inclusion requires informed consent; exclusion criteria include participation in another clinical trial within the past 4 weeks or a life expectancy of less than 28 days, as judged by the treating physician.
A total of approximately 120 patients are planned for inclusion, with the expectation that around 100 will be available for follow-up at 90 and 365 days post-discharge. Data collection includes electronic health records (Nephro7, SAP) for vital signs, laboratory values, diagnoses, and medication lists. Additional assessments include:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age: Adult patients (≥18 years)
- •Diagnosis: Confirmed diagnosis of Acute Kidney Injury (AKI) Stage 3, defined by one of the following: Increase in serum creatinine ≥3-fold from baseline, Serum creatinine ≥4 mg/dL with an acute rise of ≥0.5 mg/dL, Oliguria (<0.5 mL/kg/h for >6 hours)
- •Informed Consent: Willingness to provide written informed consent for participation in the study
排除标准
- •Participation in another clinical trial: Participation in any other interventional or observational clinical study within the last 4 weeks prior to study enrollment
- •Short life expectancy: Clinically assessed life expectancy of less than 28 days by the treating physician
- •Inability to consent: Cognitive or language barriers that prevent informed consent or participation in telephone follow-up
- •Terminal illness: Active, untreated, or progressive terminal illness (e.g., advanced cancer with no curative intent)
- •Inability to follow up: Unavailability of contact information or inability to be reached by telephone at 90 and 365 days post-discharge
结局指标
主要结局
Proportion of Participants Surviving at 90 Days
时间窗: 90 days after study inclusion
Defined as alive at 90 days post-inclusion. Assessed via telephone follow-up and medical record review.
Proportion of Participants Surviving at 365 Days
时间窗: 365 days after study inclusion
Defined as alive at 365 days post-inclusion. Assessed via telephone follow-up and medical record review.
次要结局
- Proportion of Participants Aware of AKI Diagnosis(90 days after study inclusion)
- Perceived Severity of AKI (Likert Scale)(90 days after study inclusion)
- Proportion of Participants with Follow-Up Kidney Function Testing within 90 Days(90 days after study inclusion)