Acute Kidney Injury (AKI)
Conditions
Keywords
Acute kidney injury, injury, surgery
Brief summary
The evaluation of an accurate occurrence rate for AKI is of great importance for health policy, quality initiatives as well as for designing clinical trials. The primary objective is to prospectively evaluate the incidence of AKI within 72 h after extended surgical procedures that require admission to an observation unit.
Detailed description
Acute kidney injury (AKI) is a severe clinical complication with increasing incidence and is associated with adverse short- and long-term outcomes resulting in a major health care burden worldwide. The introduction of consensus classification systems has enhanced the awareness for AKI. The evaluation of an accurate occurrence rate for AKI is of great importance for health policy, quality initiatives as well as for designing clinical trials. However, analyzing AKI from existing databases is often limited by missing data elements, especially the inclusion of the urine output criteria. Missing data and the use of different definitions before the consensus classification are the reasons for large variations in reported occurrences of surgical induced AKI. The primary objective is to prospectively evaluate the incidence of AKI within 72 h after extended surgical procedures that require admission to an observation unit (e.g., Intensive Care Unit, Intermediate Care, Post Anesthesia Care Unit) using the latest consensus definition for AKI (Kidney Disease: Improving Global Outcomes criteria) and a standardized data collection instrument and to assess the dependence of AKI on preoperative and intraoperative factors. Method: International prospective, observational, multi-center, cross-sectional cohort study Eligible patients will be identified during preoperative assessment. All eligible patients will be approached to obtain written consent.
Interventions
None listed
Sponsors
Baxter Healthcare Corporation
University Hospital Muenster
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* major elective or emergency surgery procedures with a duration of at least 2 h * admission to the intensive care unit, intermediate care unit after surgery informed consent
Exclusion criteria
* preexisting acute kidney injury * acute kidney injury within the last 3 months * end stage renal disease with dialysis dependency * kidney transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Acute Kidney Injury | 72 hours after extended surgery | Occurrence of acute kidney injury according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with renal replacement therapy | up to 90 days after extended surgery | — |
| Mortality | up to 90 days after extended surgery | — |
| Severity of acute kidney injury (number of patients with KDIGO stage 1, KDIGO stage 2 or KDIGO stage 3) | 72 hours after extended surgery | Definition and classification of acute injury according to the KDIGO (Kidney Disease: Improving Global Outcomes) clinical practice guidelines on acute kidney injury |
| Intensive Care Unit stay | up to 90 days after extended surgery (until discharge) | — |
| Major Adverse Kidney Events (MAKE) | up to 90 days after extended surgery | combined endpoint consisting of mortality, renal replacement therapy, persistent renal dysfunction defined as serum-creatinine \>= 1.5 times as compared to baseline serum-creatinine |
| Hospital stay | up to 90 days after extended surgery (until discharge) | — |
Countries
Egypt, France, Germany, Italy, Libya, Malta, North Macedonia, Palestinian Territories, Russia, Saudi Arabia, Slovenia, Spain, Turkey (Türkiye), United States
Outcome results
None listed