Acute Kidney Injury : Long-term Renal and Cardiovascular Prognosis and Biomarker-based Risk Assessment (AKIRA)
Long-term Renal and Cardiovascular Prognosis After Severe Acute Renal Failure in Intensive Care : Value of Biomarkers as Risk Stratification Tools
Patients who develop severe acute kidney injury (AKI) in intensive care remain at increased long-term risk of mortality, major cardiovascular events, and chronic renal complications, including prolonged dependence on renal replacement therapy. These adverse outcomes are thought to result from persistent inflammation, fibrosis, and cardio-renal interactions, which are not adequately captured by conventional clinical or biological markers.
This study is an ancillary analysis of the AKIKI 2 trial. The main objective is to assess whether biomarkers of inflammation and fibrosis, specifically galectin-3 (Gal-3) and CD146, measured during the acute phase of AKI, can predict and stratify long-term cardio-renal risk in patients who survived to day 60 after severe AKI in the ICU.
The primary endpoint is the occurrence, between day 60 and the last follow-up, of a composite cardio-renal outcome, defined as the first occurrence of:
- a major cardiovascular event (myocardial infarction, stroke, or hospitalization for heart failure),
- a major renal event (chronic dialysis dependence or progression to severe chronic kidney disease),
- or death from any cause.
Secondary objectives include :
- describing the long-term incidence of major renal events (MAKE),
- describing the incidence of major cardiovascular events (MACE),
- evaluating the predictive ability of Gal-3 and CD146 for the occurrence of MAKE,
- evaluating their ability to predict long-term MACE and deterioration of cardiovascular function.
The study population will include patients from the AKIKI 2 trial who are alive at day 60. Follow-up data (creatinine levels, dialysis dependence, cardiovascular events, etc.) will be collected through telephone interviews with patients and their referring physicians. When appropriate, a cardiology referral will be recommended as part of routine clinical care.
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Khalil CHAIBI, Dr
- 電話番号:00 33 1 48 95 52 41
- メール:khalil.chaibi@aphp.fr
研究場所
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Bobigny、フランス
- Réanimation médico-chirurgicale, Hôpital Avicenne
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コンタクト:
- Khalil CHAIBI, Dr
- 電話番号:00 33 1 48 95 52 41
- メール:khalil.chaibi@aphp.fr
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 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
The population comes from the AKIKI-2 cohort, which included adult patients (≥18 years) in intensive care, under mechanical ventilation and/or catecholamines, presenting severe acute renal failure (KDIGO 3) complicated by oligo-anuria ≥72 h or uremia between 40 and 50 mmol/L.
For the present study, the eligible population is defined among patients surviving to day 60 since their inclusion, 412 subjects out of the 757 initially included. Of these 412 subjects, 214 recovered spontaneously during the observational phase, 57 had an EER initiated during the observational phase, and 141 participated in the randomized phase.
説明
Inclusion Criteria:
The study population concerns patients included in the AKIKI 2 study who survive 60 days after inclusion in the AKIKI 2 study.
Exclusion Criteria:
Patients opposed to their participation
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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Patients AKIKI2
The study population will include patients from the AKIKI 2 trial who are alive at day 60.
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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 |
|---|---|---|
|
Occurrence, between 60 days after inclusion in the AKIKI 2 study and the date of the last news, of a composite cardio-renal criteria defined by the occurrence of a MACE and/or a MAKE criteria or death from all causes, the first event being retained
時間枠:Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.
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Composite criteria : occurrence, between day 60 (60 days after inclusion in the AKIKI 2 study) and the date of the last news, of a cardio-renal composite criteria defined by the occurrence of a major cardiovascular event (myocardial infarction, stroke, hospitalization for heart failure) and/or a major renal event (dependence on chronic dialysis, progression to severe chronic renal failure) or death from all causes, the first event being retained.
|
Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.
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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 |
|---|---|---|
|
Occurrence, between day 60 and the date of the latest news, of a MAKE criteria, the first event being retained
時間枠:Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.
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Occurrence, between day 60 (after inclusion in the AKIKI 2 study) and the date of the last news, of a MAKE criteria defined by dependence on chronic dialysis or by progression towards severe chronic renal failure (stage 4 or 5 KDIGO), the first event being retained
|
Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.
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Occurrence, between day 60 and the date of the latest news, of a MACE criteria, the first event being retained
時間枠:Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.
|
Occurrence, between day 60 (after inclusion in the AKIKI 2 study) and the date of the last news, of a MACE criteria defined by a myocardial infarction or a stroke or hospitalization for heart failure, the first event being retained
|
Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.
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Diagnosis between day 60 and the date of the last news of a heart failure diagnosed in town via echocardiography
時間枠:Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.
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The diagnosis of heart failure will be established in the event of compatible clinical symptoms (dyspnea, congestive signs) with ultrasound :
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Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- APHP251915
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?
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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