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

NCT06722924 | Not Yet Recruiting

• 1 other identifier: AKI-UO
• Study Type: observational
• Target: 15,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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?

Conditions

Acute Kidney Injury; Critical Illness; Critical Care, Intensive Care; Critical Care, Fluid Resuscitation

Keywords

observational study

Outcome Measures

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

  Seven days rolling window.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• Minimum age 18 years

Sponsors & Collaborators

• Uppsala University: lead

MeSH Terms

Conditions

Acute Kidney Injury; Critical Illness

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mikael Eriksson, MD, PhD

CONTACT

+46186110000; mikael.e.eriksson@uu.se

Study Design

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

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 9, 2024
• Study Start: December 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share