Nephroprotective Measures in Critically Ill Patients With Moderate/Severe Acute Kidney Injury (KDIGO-Bundle)

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

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

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Procedure: Nephroprotective measures

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 Type: Observational
• Enrollment (Estimated): 257

Contacts and Locations

• Study Contact: Name: Melanie Meersch-Dini, MD; Phone Number: +492518347255; Email: meersch@uni-muenster.de

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Recruiting
    • Universitatsklinik Innsbruck
• Germany
  • Münster, Germany, 48149
    • Recruiting
    • University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pain Medicine
    • Contact: Meersch, MD; Email: aki@uni-muenster.de
• Netherlands
  • Nijmegen, Netherlands, 6500
    • Recruiting
    • Radboud University medical cener

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Critically ill patients (intensive care unit of the participating study sites)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Critically ill patients	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Acute Kidney Injury	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)	within 72 hours after diagnosis
Duration of AKI (Acute Kidney Injury)	transient AKI (< 48 hours), persistent AKI (48 hours - 7 days) or acute kidney disease (AKD) (> 7 days)	from onset of AKI until follow-up day 30

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Free-days of mechanical ventilation		within 30 days of AKI onset
Length of hospital stay		at hospital discharge (up to 30 days)
Length of Intensive Care Unit stay		at hospital discharge (up to 30 days)
Mortality		at day 90
Number of participants with recovery of baseline renal function	recovery of baseline renal function measured by estimated glomerular filtration rate (eGFR) at hospital discharge	hospital discharge (up to 30 days)
Number of Participants with need for renal replacement therapy	defined as whether or not any kind of renal replacement therapy became necessary at any point	within 30 days of AKI onset
Number of Participants with renal replacement therapy		at day 90

Collaborators and Investigators

• Sponsor: Universität Münster
• Investigators: Principal Investigator: Alexander Zarbock, MD, University Münster

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: June 11, 2024
• First Submitted That Met QC Criteria: June 18, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Acute Kidney Injury; KDIGO; Bundle; Nephroprotective
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury; Wounds and Injuries
• Other Study ID Numbers: AnIt23-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No