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NCT Number: NCT06472999

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinik Innsbruck, Innsbruck, Austria

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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)

    Time frame: 60 hours after onset of moderate/severe AKI

Secondary outcomes

  1. Severity of Acute Kidney Injury

    Time frame: 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)

  2. Duration of AKI (Acute Kidney Injury)

    Time frame: 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)

Other outcomes

  1. Number of participants with recovery of baseline renal function

    Time frame: hospital discharge (up to 30 days)

    recovery of baseline renal function measured by estimated glomerular filtration rate (eGFR) at hospital discharge

  2. Number of Participants with need for renal replacement therapy

    Time frame: within 30 days of AKI onset

    defined as whether or not any kind of renal replacement therapy became necessary at any point

  3. Free-days of mechanical ventilation

    Time frame: within 30 days of AKI onset

  4. Length of hospital stay

    Time frame: at hospital discharge (up to 30 days)

  5. Length of Intensive Care Unit stay

    Time frame: at hospital discharge (up to 30 days)

  6. Number of Participants with renal replacement therapy

    Time frame: at day 90

  7. Mortality

    Time frame: at day 90

Study contacts

Contact information is provided by the study sponsor or research team.

Melanie Meersch-Dini, MD

CONTACT

[email protected]

+492518347255

Sponsors and collaborators

Lead sponsor

Universität Münster

Other

Registry information

Official study title

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

Acronym: KDIGO-Bundle

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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