Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Acute Kidney Injury : Long-term Renal and Cardiovascular Prognosis and Biomarker-based Risk Assessment (AKIRA)

13 de maio de 2026 atualizado por: Assistance Publique - Hôpitaux de Paris

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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Tipo de estudo

Observacional

Inscrição (Estimado)

412

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

      • Bobigny, França
        • Réanimation médico-chirurgicale, Hôpital Avicenne
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Patients AKIKI2
The study population will include patients from the AKIKI 2 trial who are alive at day 60.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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
Prazo: 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.
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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Occurrence, between day 60 and the date of the latest news, of a MAKE criteria, the first event being retained
Prazo: 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 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.
Occurrence, between day 60 and the date of the latest news, of a MACE criteria, the first event being retained
Prazo: 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.
Diagnosis between day 60 and the date of the last news of a heart failure diagnosed in town via echocardiography
Prazo: 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.

The diagnosis of heart failure will be established in the event of compatible clinical symptoms (dyspnea, congestive signs) with ultrasound :

  • impaired LVEF under 40 %
  • a moderately impaired LVEF, between 41 and 49%
  • a preserved LVEF more than 50% associated with structural abnormalities (left ventricular hypertrophy, left atrial dilatation) and/or functional (elevation of left ventricular filling pressures and/or PAPs estimated > 35 mmHg or a Vmax > 2.8 m/s) in a context of increased natriuretic peptides (BNP > 35 ng/L or NT-proBNP > 125 ng/L)
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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

30 de maio de 2027

Conclusão do estudo (Estimado)

30 de maio de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

13 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de maio de 2026

Primeira postagem (Real)

19 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

19 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever