- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07596407
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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Khalil CHAIBI, Dr
- Telefonnummer: 00 33 1 48 95 52 41
- E-Mail: khalil.chaibi@aphp.fr
Studienorte
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Bobigny, Frankreich
- Réanimation médico-chirurgicale, Hôpital Avicenne
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Kontakt:
- Khalil CHAIBI, Dr
- Telefonnummer: 00 33 1 48 95 52 41
- E-Mail: khalil.chaibi@aphp.fr
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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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
Zeitfenster: 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.
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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.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Occurrence, between day 60 and the date of the latest news, of a MAKE criteria, the first event being retained
Zeitfenster: 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
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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.
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Occurrence, between day 60 and the date of the latest news, of a MACE criteria, the first event being retained
Zeitfenster: 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 MACE criteria defined by a myocardial infarction or a stroke or hospitalization for heart failure, the first event being retained
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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.
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Diagnosis between day 60 and the date of the last news of a heart failure diagnosed in town via echocardiography
Zeitfenster: 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.
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Pathologische Prozesse
- Männliche Urogenitalerkrankungen
- Nierenerkrankungen
- Urologische Erkrankungen
- Weibliche Urogenitalerkrankungen
- Weibliche Urogenitalerkrankungen und Schwangerschaftskomplikationen
- Chronische Erkrankung
- Krankheitsattribute
- Niereninsuffizienz
- Niereninsuffizienz, chronisch
- Pathologische Zustände, Anzeichen und Symptome
- Akute Nierenschädigung
- Nierenversagen, chronisch
Andere Studien-ID-Nummern
- APHP251915
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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