NCT04165369

Observational Study to Evaluate the Epidemiology of Surgical-induced Acute Kidney Injury

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10,568 (actual)
• Sponsor: University Hospital Muenster · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Kidney Injury (AKI)

Timeline

• Start date: 2020-06-09
• Primary completion: 2022-02-28
• Completion: 2022-03-31
• First posted: 2019-11-18
• Last updated: 2022-07-21

Locations

82 sites across 14 countries: United States, Egypt, France, Germany, Italy, Libya, Malta, North Macedonia, Palestinian Territories, Russia, Saudi Arabia, Slovenia, Spain, Turkey (Türkiye)