The PrevAKI Study
Winner of the 2016 Trials Group award, PrevAKI is a multicentre, prospective, randomised controlled parallel group trial, which will assess biomarker-guided implementation of the KDIGO guidelines in the prevention of AKI.
Acute kidney injury (AKI) is a well-recognised complication after cardiac surgery and is associated with an increased morbidity and mortality. The KDIGO guidelines recommend the implementation of a variety of measures in patients with increased risk, but it is not clear whether this approach can prevent the occurrence of AKI in patients undergoing cardiac surgery or precisely how to determine risk. We hypothesise that a biomarker-guided implementation of the KDIGO guidelines reduces the occurrence of AKI in patients after cardiac surgery.
The aim is to conduct a prospective, randomised, multicentre, controlled feasibility study including 280 cardiac surgery patients at high risk for AKI identified by a validated AKI biomarker test—[TIMP2]*[IGFBP7]. We propose to investigate the effect of the implementation of the KDIGO guidelines in patients at high risk for AKI after cardiac surgery compared to standard of care in the same patient population.
The primary outcome will be the compliance rate (proportion of patients who have been treated according to the protocol).
Secondary endpoints are:
- Occurrence of AKI according to the KDIGO guidelines within the first 72 hours after cardiac surgery
- The severity of AKI (KDIGO stage)
- renal recovery at days 30, 60, 90
- 30-day, 60-day and 90-day mortality
- length of ICU stay / length of hospital stay
- need and duration of RRT
- RRT at days 30, 60, 90
- MAKE30, MAKE60, MAKE90 (major adverse kidney events consisting of mortality, dialysis dependency persistent renal dysfunction (defined as serum creatinine ≥ 2x to baseline value at hospital discharge)
HYPOTHESIS: Implementation of the KDIGO guidelines in cardiac surgery patients at high risk for AKI identified by biomarker reduces the occurrence of AKI by approximately 15% compared to standard care.
Data collection is set to begin in 2017.
We plan to randomise 280 patients (140 per treatment arm) according to the power analysis and we estimate that it will take up to 8 months for the recruitment of the calculated patients.
What data is required?
- Patients undergoing cardiac surgery with cardiopulmonary bypass (CPB)
- [TIMP-2]*[IGFBP7] concentrations ≥ 0.3 at 4 h after CPB
- Age between 18 and 90 years
- Written informed consent
- Preexisting acute kidney injury
- (Glomerulo-) Nephritis, interstitial nephritis or vasculitis
- Chronic kidney disease with eGFR < 30 ml/min
- Dialysis dependent chronic kidney disease
- Prior kidney transplant
- Participation in another intervention trial within the last 3 months
- Persons with any kind of dependency on the investigator or employed by the responsible institution or investigator
- Persons held in an institution by legal or official order
After identifying patients at high risk for AKI, patients will be randomised to a control group or to the intervention group.
Experimental intervention / index test: Implementation of the KDIGO guidelines:
1) Discontinuation of all nephrotoxic agents (e.g. ACE inhibitors)
2) Optimisation of volume status and perfusion pressures according to a pre-specified protocol
3) Consideration of functional haemodynamic monitoring
4) Close monitoring of serum creatinine and urine output
5) Avoidance of hyperglycemia
6) Consideration of alternatives to radio contrast agents.
Control intervention / reference test: Patients in the control group are treated according to the standard of care. The only two targets in this group are mean arterial pressure (MAP>65mmHg) and central venous pressure (8-12mmHg).
Follow-up per patient: Up to 90 days after randomisation.
Duration of intervention per patient: For 12 hours after randomisation.
Do I need IRB approval?
Yes. You will need to check with your local ethical committee and/ or with your national coordinator if any.
How is the data that is collected managed?
All data is anonymised and cannot be linked to individual subjects. The data is stored securely and all procedures regarding data management will comply with EU directive on data protection 95/46/EC.
Who owns and can access the collected data?
Each site investigator is responsible for his own data and may request an export of his data after the database is locked. The request should be addressed to the Principal Investigator.
Is there any financial compensation?
No. Participation in the trial is completely voluntary.
What about authorship?
Results from the trial will be published by the PrevAKI nominated writing Committee. Investigators will be acknowledged as collaborators in the authorship of the paper and as such, listed in PubMed.
How do I participate?
Selected sites will be contacted shortly.
Any further Questions?
Contact: Guy FRANCOIS / Sherihane BENSEMMANE – email@example.com
Univ.-Prof. Dr. med. Alexander Zarbock
Department of Anesthesiology and Critical Care Medicine
Albert-Schweitzer Campus 1, Building A1
48149 Münster, Germany
Meersch M, Schmidt C, Hoffmeier A, et al. Prevention of cardiac surgery-associated AKI by implementing the KDIGO guidelines in high risk patients identified by biomarkers: the PrevAKI randomised controlled trial
- Protocol: available soon