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

NCT06472999 | Recruiting

• 1 other identifier: AnIt23-10
• Study Type: observational
• Target: 257
• Locations: 3 countries
• Sites: 3

Brief Summary

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

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injury; KDIGO; Nephroprotective; Bundle

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Severity of Acute Kidney Injury

  within 72 hours after diagnosis

• Duration of AKI (Acute Kidney Injury)

  from onset of AKI until follow-up day 30

Other Outcomes (7)

• Number of participants with recovery of baseline renal function

  hospital discharge (up to 30 days)

• Number of Participants with need for renal replacement therapy

  within 30 days of AKI onset

• Free-days of mechanical ventilation

  within 30 days of AKI onset

Study Arms (1)

Critically ill patients

Procedure: Nephroprotective measures

Interventions

Nephroprotective measures PROCEDURE

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.

Critically ill patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universität Münster: lead

Study Sites (3)

Universitätsklinik Innsbruck

Innsbruck, 6020, Austria

RECRUITING

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

Münster, 48149, Germany

RECRUITING

Radboud University medical cener

Nijmegen, 6500, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma, urine

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Alexander Zarbock, MD

  University Münster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie Meersch-Dini, MD

CONTACT

+492518347255; meersch@uni-muenster.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 25, 2024
• Study Start: July 24, 2024
• Primary Completion: March 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); DE (1); NL (1)