Definition of Acute Kidney Injury by Urine Output in Critically Ill Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUppsala University

About this trial

The goal of this observational study is to explore the association between urine output and acute kidney injury in severely ill patients admitted to intensive care units. The main research questions are:

What is the optimal threshold for defining reduced urine output in critically ill patients in intensive care? Is this threshold the same for different outcomes such as acute kidney injury, chronic kidney dysfunction, or mortality? Does this threshold change with treatment involving diuretics or dialysis? Does the patient's fluid balance or the amount of administered fluid affect the association between reduced urine output and the outcomes mentioned above? Is the optimal threshold for defining reduced urine output different for various patient categories and diagnoses, such as sepsis, burn injuries, or ARDS? Are there differences between surgical and non-surgical patients regarding the optimal threshold for defining reduced urine output in intensive care? Does the patient's comorbidity influence the level of reduced urine output that should be considered pathological?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Admittance to intensive care units at Uppsala University Hospital between 2016-2024

Disqualifiers

Minimum age 18 years

Trial population

The study population will be adult patients (\>17 years of age) who have received care in the intensive care unit at Akademiska Sjukhuset since the implementation of the Metavision (an electronic medical record system used in anesthesia and intensive care (Patient Data Management System, PDMS)) from 2016-2017 (depending on the unit) up until the study start in 2024. To enable subgroup analyses and improve the reliability of estimates, the largest possible cohort is desired. Children will not be included in the study, as their urine production and normal reference values for blood markers of kidney function vary with age and differ from those of adults.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Acute Kidney Injury according to KDIGO creatinine criteria.

AKI by creatinine criteria is defined as any of the following: 1) Increase in SCr by ≥26.5 umol/l within 48 hours; or 2) Increase in SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days. Further, the severity of AKI is staged in 3 levels: 1) SCr 1.5-1.9 times baseline OR ≥26.5 umol/l increase; 2) SCr 2.0-2.9 times baseline; 3) SCr 3.0 times baseline OR increase in serum creatinine to ≥353.6 umol/l OR initiation of renal replacement therapy

Time frame
Seven days rolling window.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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