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Recruiting NCT06472999

Nephroprotective Measures in Critically Ill Patients With Moderate/Severe Acute Kidney Injury

Observational Acute Kidney Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nephroprotective measures.
Who it may be relevant to
Registry conditions: Acute Kidney Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria, Germany, Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Implementation of Nephroprotective Measures in Critically Ill Patients With Moderate/Severe Acute Kidney Injury (AKI) - an Observational Study

Overview

This study investigates to which extent recommended nephroprotective measures are implemented in critically ill patients with moderate or severe acute kidney injury.

Detailed description

Acute kidney injury (AKI) is a global problem affecting more than 10% of all hospitalized patients and up to 50% of critically ill patients, with survival related not only to the severity,1 but also to the duration of renal dysfunction.2 Recent evidence suggests that two-thirds of patients with AKI resolve their renal dysfunction within 3-7 days whereas those in whom renal dysfunctions persist have dramatically reduced survival over the following year.2 Persistence of AKI is of grave importance in that it increases an individual's risk of developing chronic kidney disease (CKD) which is a major cause of morbidity and mortality. This link between AKI and CKD has been established over the last decade3 and specific recommendations for the management of patients with AKI have been proposed in order to potentially influence this transition.4 To date, there are no specific pharmacological options for preventing or treating AKI, which is why new approaches and intensive efforts are urgently needed to reduce the occurrence of AKI. The Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guidelines recommend implementing a bundle of different supportive measures, which, in theory, should be initiated in all patients with AKI in order to prevent disease progression. However, clinical practice and recent studies have shown that the implementation of the KDIGO bundle is still not standard clinical practice despite the fact that evidence suggest clear effectiveness in the reduction of AKI rates.5-9 Poor implementation of nephroprotective measures presents a major missed opportunity to reduce AKI-related morbidity and mortality and to improve long-term outcomes. To investigate the extent to which nephroprotective measures are implemented in patients with AKI can reduce the occurrence of persistent surgical AKI, a multi-center prospective cohort study will be performed.

Interventions

  • Procedure Nephroprotective measures
    Due to the observational design of the study, no study specific interventions are performed. The treatment of the patients is completely guided by the responsible physicians.

Primary outcome measures

  • Rate of patients in whom "Kidney Disease: Improving Global Outcomes (KDIGO)" guideline recommendations are successfully implemented for 48 hours, following the onset of moderate/ severe AKI (defined by KDIGO criteria) [Time frame: 60 hours after onset of moderate/severe AKI]
Secondary outcome measures (2)
  • Severity of Acute Kidney Injury [Time frame: within 72 hours after diagnosis]
  • Duration of AKI (Acute Kidney Injury) [Time frame: from onset of AKI until follow-up day 30]

Eligibility criteria

Inclusion criteria

  • Critically ill patients with moderate or severe AKI (KDIGO stage 2 / 3)
  • Requirement of vasopressors or mechanical ventilation
  • Age ≥ 18 years
  • Informed consent

Exclusion criteria

  • Chronic kidney disease (CKD) with a glomerular filtration rate < 20ml/min
  • Chronic dialysis dependency
  • History of renal transplantation
  • Permanent ligation of the renal arteries
  • AKI immediately following nephrectomy
  • Patients requiring permanent administration of nephrotoxic drugs (e.g. immunosuppressive therapy afer liver transplantation)
  • Persons with any kind of dependency on the investigator or employed by the sponsor or investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Austria · 1 center
  • Universitätsklinik Innsbruck — Innsbruck
Germany · 1 center
  • University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pai — Münster
Netherlands · 1 center
  • Radboud University medical cener — Nijmegen

Identifiers

NCT: NCT06472999 · AnIt23-10

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗