Clinical trial NCT06472999: Nephroprotective Measures in Critically Ill Patients With Moderate/Severe Acute Kidney Injury
Official title: Implementation of Nephroprotective Measures in Critically Ill Patients With Moderate/Severe Acute Kidney Injury (AKI) - an Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Keywords: Acute Kidney Injury
KDIGO
Nephroprotective
Bundle
Lead sponsor: Universität Münster
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients (intensive care unit of the participating study sites)

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: 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)
timeFrame: 60 hours after onset of moderate/severe AKI
Secondary outcomes:
measure: Severity of Acute Kidney Injury
timeFrame: within 72 hours after diagnosis
measure: Duration of AKI (Acute Kidney Injury)
timeFrame: from onset of AKI until follow-up day 30
Other outcomes:
measure: Number of participants with recovery of baseline renal function
timeFrame: hospital discharge (up to 30 days)
measure: Number of Participants with need for renal replacement therapy
timeFrame: within 30 days of AKI onset
measure: Free-days of mechanical ventilation
timeFrame: within 30 days of AKI onset
measure: Length of hospital stay
timeFrame: at hospital discharge (up to 30 days)
measure: Length of Intensive Care Unit stay
timeFrame: at hospital discharge (up to 30 days)
measure: Number of Participants with renal replacement therapy
timeFrame: at day 90
measure: Mortality
timeFrame: at day 90
Locations:
city: Innsbruck
country: Austria
facility: Universitätsklinik Innsbruck
city: Münster
country: Germany
facility: University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pain Medicine
city: Nijmegen
country: Netherlands
facility: Radboud University medical cener
Study officials:
affiliation: University Münster
name: Alexander Zarbock, MD
role: PRINCIPAL_INVESTIGATOR
References: