Body Composition, Kidney Size, and Medication Dosing in Acute Kidney Injury: Follow-Up at 90 Days and 12 Months
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
調査の概要
状態
条件
詳細な説明
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:
- Body composition analysis using non-invasive bioimpedance spectroscopy (50 frequencies, 5-1000 kHz) to measure total body water, extracellular water, muscle mass, and fat mass. Overhydration (>1000 mL) is a primary outcome.
- Point-of-care ultrasound of the kidneys to assess kidney length (<10 cm), parenchymal thickness (<10 mm), and signs of chronic kidney disease or obstruction. Findings are correlated with estimated glomerular filtration rate (eGFR <45 mL/min).
- Medication review using the national standardized medication plan (Bundesmedikationsplan), supplemented by a joint evaluation by a nephrologist and clinical pharmacist to identify dosing errors, contraindications, or nephrotoxic drugs.
Patients are contacted by telephone at 90 and 365 days after AKI diagnosis to assess:
- Awareness of the AKI diagnosis (Yes/No),
- Perceived severity of the event (Likert scale: 1-5),
- Health literacy regarding AKI (Likert scale: 1-5),
- Whether kidney function (serum creatinine, urea, potassium) was rechecked by their primary care provider within 90 days.
All data are anonymized and stored securely on hospital servers. The study is non-interventional; no changes to standard care are made. The only interventions are the assessments and follow-up calls. The study is ethically approved and conducted in accordance with GDPR and local regulations.
The anticipated benefits include improved patient safety through early detection of fluid imbalance, kidney structural changes, and medication errors. The follow-up calls may prompt overdue kidney function checks by primary care providers. Risks are minimal: potential anxiety from the phone call is mitigated by trained staff and clear communication. The study is considered medically justified as it enhances care quality beyond routine practice.
Data collection concludes with the final follow-up call at 365 days post-AKI alert. Results will inform strategies to improve AKI management, patient education, and post-discharge monitoring, ultimately reducing complications and improving long-term outcomes.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Braunschweig、ドイツ
- Academic Teaching Hospital Braunschweig
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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AKI Stage 3
Patients (≥18 years) with stage 3 acute kidney injury (AKI) as defined by the following criteria: a ≥3-fold increase in serum creatinine from baseline, a serum creatinine level ≥4 mg/dL with an acute rise of ≥0.5 mg/dL, or oliguria (<0.5 mL/kg/h for >6 hours).
Patients were identified via the institutional AKI alert system and confirmed by a nephrologist.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Proportion of Participants Surviving at 90 Days
時間枠:90 days after study inclusion
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Defined as alive at 90 days post-inclusion.
Assessed via telephone follow-up and medical record review.
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90 days after study inclusion
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Proportion of Participants Surviving at 365 Days
時間枠:365 days after study inclusion
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Defined as alive at 365 days post-inclusion.
Assessed via telephone follow-up and medical record review.
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365 days after study inclusion
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of Participants Aware of AKI Diagnosis
時間枠:90 days after study inclusion
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Assessed via structured telephone interview: "Do you know you had acute kidney injury during your hospital stay?" (Yes/No).
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90 days after study inclusion
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Perceived Severity of AKI (Likert Scale)
時間枠:90 days after study inclusion
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Assessed using a 5-point Likert scale: 1 = not severe, 2 = slightly severe, 3 = moderately severe, 4 = severely severe, 5 = very severely severe.
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90 days after study inclusion
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Proportion of Participants with Follow-Up Kidney Function Testing within 90 Days
時間枠:90 days after study inclusion
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Defined as serum creatinine, urea, and potassium measured by the primary care provider within 90 days of study inclusion.
Confirmed via patient report and primary care medical record review.
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90 days after study inclusion
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Jan T Kielstein, MD、Academic Teaching Hospital Braunschweig
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- B3 D2 AKI - Study
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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