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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06472999
Acronym
KDIGO-Bundle
Enrollment
257
Registered
2024-06-25
Start date
2024-07-24
Completion date
2025-09-30
Last updated
2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury, KDIGO, Nephroprotective, Bundle

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.

Interventions

PROCEDURENephroprotective 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.

Sponsors

Universität Münster
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frameDescription
Severity of Acute Kidney Injurywithin 72 hours after diagnosisSeverity 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 30transient AKI (\< 48 hours), persistent AKI (48 hours - 7 days) or acute kidney disease (AKD) (\> 7 days)

Other

MeasureTime frameDescription
Length of hospital stayat hospital discharge (up to 30 days)
Length of Intensive Care Unit stayat hospital discharge (up to 30 days)
Number of participants with recovery of baseline renal functionhospital discharge (up to 30 days)recovery of baseline renal function measured by estimated glomerular filtration rate (eGFR) at hospital discharge
Mortalityat day 90
Number of Participants with renal replacement therapyat day 90
Number of Participants with need for renal replacement therapywithin 30 days of AKI onsetdefined as whether or not any kind of renal replacement therapy became necessary at any point
Free-days of mechanical ventilationwithin 30 days of AKI onset

Countries

Austria, Germany, Netherlands

Contacts

Primary ContactMelanie Meersch-Dini, MD
meersch@uni-muenster.de+492518347255

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026