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

Recruiting

• Conditions: Acute Kidney Injury
• Interventions: Procedure: Nephroprotective measures

• Registration Number: NCT06472999
• Lead Sponsor: Universität Münster

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.

Study Timeline

• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-18
• Study First Posted: 2024-06-25
• Study Start: 2024-07-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-12
• Primary Completion: 2025-03
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 257

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Critically ill patients	Nephroprotective measures	-

Primary Outcome Measures

Name	Time	Method
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)	60 hours after onset of moderate/severe AKI

Secondary Outcome Measures

Name	Time	Method
Severity of Acute Kidney Injury	within 72 hours after diagnosis	Severity of AKI (worst Acute Kidney Injury (AKI) stage according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria, with stage 1 being the least and stage 3 being the most severe stage)
Duration of AKI (Acute Kidney Injury)	from onset of AKI until follow-up day 30	transient AKI (\< 48 hours), persistent AKI (48 hours - 7 days) or acute kidney disease (AKD) (\> 7 days)

Trial Locations

Locations (3)

Universitätsklinik Innsbruck; 🇦🇹 Innsbruck, Austria

Radboud University medical cener; 🇳🇱 Nijmegen, Netherlands

University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pain Medicine; 🇩🇪 Münster, Germany