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Completed

NCT Number: NCT04242615

Acute Kidney Injury in Non-Critical Care Setting: Elaboration and Validation of an In-hospital Death Prognosis Score

Acute renal failure (AKI) is defined by a deterioration of kidney function over a short period. This definition was clarified recently in order to allow homogenization and optimal comparison of patients in clinical studies by the classifications RIFLE in 2004, AKIN in 2007 and KDIGO in 2013. These classifications decline several stages of ARI through the increase in the plasma creatinine level and the decrease in urine flow.

Even though AKI is a frequent pathology in all hospitalized patients, there are only few studies that are interested in this entity in conventional hospital services except intensive care or intensive care. Indeed, the recent meta-analysis including the 154 studies focusing on the ARI defined by the KDIGO criteria, only 7 have recruited patients in conventional nephrology services. However, patients admitted for an ARI which requires treatment in a medical service probably have epidemiological characteristics and a different prognosis than those requiring treatment in intensive care. In addition, the parameters of the RIFLE, AKIN or KDIGO scores are more difficult to establish in conventional hospital services than in intensive care, especially for hourly monitoring of urine flow, not allowing an optimal classification of the episode of IRA.

This study set out to develop a prognostic score for intra-hospital mortality in ARI based on a first historical cohort. The investigators then validated this score on a second prospective cohort obtained over an independent inclusion period and at a distance from the first.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patients over 18 years of age admitted for ARI, defined by an increase in serum creatinine of more than 50% of baseline serum creatinine in patients without chronic kidney disease or an increase in serum creatinine greater than 100 umol / L compared to baseline serum creatinine if the patient had a serum creatinine clearance less than 60 mL / min / 1.73m2 calculated by the MDRD formula (Modification of the Diet in Renal Disease), hospitalized in the Nephrology department of the Besançon University Hospital Center

Exclusion criteria

  • kidney transplant and patients from an intensive care unit

Treatment and study plan

Prognostic score

Other

Primary outcomes

  1. Risk of intra-hospital mortality

    Time frame: 4 years

    Association between the clinical and biological parameters collected at the entry of patients included in the first cohort and the risk of intra-hospital mortality

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: AKI-DPS

Important dates

Study start
2001
Primary completion
2013
Study completion
2013
First posted
Jan 27, 2020
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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