Observational Study to Evaluate the Epidemiology of Surgical-induced Acute Kidney Injury (Epis-AKI)
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| ClinicalTrials.gov Identifier: NCT04165369 |
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Recruitment Status :
Completed
First Posted : November 18, 2019
Last Update Posted : July 21, 2022
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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.
| Condition or disease |
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| Acute Kidney Injury (AKI) |
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.
| Study Type : | Observational |
| Actual Enrollment : | 10568 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Observational Study to Evaluate the Epidemiology of Surgical-induced Acute Kidney Injury |
| Actual Study Start Date : | June 9, 2020 |
| Actual Primary Completion Date : | February 28, 2022 |
| Actual Study Completion Date : | March 31, 2022 |
| Group/Cohort |
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Patients with extended surgical exposures
Patients with extended surgical exposures requiring postoperative observation.
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- Incidence of Acute Kidney Injury [ Time Frame: 72 hours after extended surgery ]Occurrence of acute kidney injury according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria
- Severity of acute kidney injury (number of patients with KDIGO stage 1, KDIGO stage 2 or KDIGO stage 3) [ Time Frame: 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
- Number of patients with renal replacement therapy [ Time Frame: up to 90 days after extended surgery ]
- Mortality [ Time Frame: up to 90 days after extended surgery ]
- Hospital stay [ Time Frame: up to 90 days after extended surgery (until discharge) ]
- Intensive Care Unit stay [ Time Frame: up to 90 days after extended surgery (until discharge) ]
- Major Adverse Kidney Events (MAKE) [ Time Frame: 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04165369
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| Study Chair: | Alexander Zarbock, MD, PhD | University Hospital Muenster, Dept. of Anesthesiology, Intensive Care and Pain Medicine |
| Responsible Party: | University Hospital Muenster |
| ClinicalTrials.gov Identifier: | NCT04165369 |
| Other Study ID Numbers: |
01-AnIt-19 |
| First Posted: | November 18, 2019 Key Record Dates |
| Last Update Posted: | July 21, 2022 |
| Last Verified: | July 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Acute kidney injury injury surgery |
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Acute Kidney Injury Wounds and Injuries Renal Insufficiency Kidney Diseases Urologic Diseases |