Biomarkers for renal recovery - a translational approach for outcome assessment of critically ill patients with acute kidney injury
- Conditions
- N17Acute renal failure
- Registration Number
- DRKS00021444
- Lead Sponsor
- niversitätsklinikum Münster; Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie
- Brief Summary
Proteomic analyses demonstrated high levels of alpha-1 microglobulin protein (AMBP) in patients with AKI progression. ROC analyses of AMBP for short-term renal recovery revealed an AUC of 0.906 (95% CI, 0.859 to 0.953) at baseline, 0.684 (95% CI, 0.596 to 0.771) at day 1, 0.750 (95% CI, 0.668 to 0.833) at day 2, and 0.799 (95% CI, 0.713 to 0.884) at day 7 after enrolment. Based on the results, we decided to focus on AMBP at baseline and at day 1. We included 500 patients with KDIGO stage 2/3 (417 (83.4%) with KDIGO stage 2 and 83 (16.6%) with KDIGO stage 3) between December 2016 and December 2018. The mean age was 64.6 (±15.1) years and 70.6% (353) patients were male. The AUC of AMBP at the day of enrolment and day 1 after enrolment for short-term renal recovery was 0.801 (95% CI, 0.762 to 0.841; p<0.0001) and 0.693 (95% CI, 0.644 to 0.741), respectively, and for renal recovery at day 90 AUC 0.624 (95% CI, 0.565 to 0.683) and 0.581 (95% CI, 0.519 to 0.0.644), respectively. The predictive performance of AMBP for renal recovery after 1 year resulted in an AUC 0.641 (95% CI, 0.574 to 0.708) for the day of enrolment and 0.624 (95% CI, 0.0.554 to 0.694) at day 1 after enrolment. Regarding the secondary endpoint, 58.8% (295%500) of the patients suffered from transient AKI and had short-term renal recovery, 34.7% (174/350) recovered renal function after 90 days, 16.9% (85/279) after 365 years. 4 (1.1%) patients at day 90 and 3 (0.8%) patients at day 365 were still dialysis dependent. Mortality rates were 25.9% at day 90 and 29.5% at day 365. MAKE was 35.3% (177/347) at day 90 and 39.0% (196/279) at day 365. The pilot cohort revealed a high predictive performance for transient AKI or short term renal recovery and this could be confirmed in the complete ‘RenalRecovery’ cohort. However, in the long-term after 90 and 365 days, predictive performance was poor.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 500
1.Critically ill patients with KDIGO stage 2 and 3
2.Age 18 – 90 years
3.Informed consent
1.Previous renal replacement therapy due to AKI in the last 90 days
2.chronic kidney disease with a glomerular filtration rate < 30 ml/min
3.Dialysis-dependent chronic kidney insufficiency
4.Kidney transplant within the last 12 months
5.AKI caused by permanent occlusion or surgical lesion of the renal artery
6.AKI caused by (glomerulo)nephritis, interstitial nephritis, vasculitis
7.Prenancy or nursing period
8.Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Predictive value of biomarkers for renal recovery (short- and long-term).
- Secondary Outcome Measures
Name Time Method • AKI progression (=persistent AKI with a duration of =72h) AND short-term renal recovery (=transient AKI)<br>• Renal recovery at days 90 and 365<br>• Dialysis dependency at days 90 and 365<br>• Mortality at days 90 and 365<br>• MAKE 90, 365 (=Major adverse kidney events: combined endpoint consisting of persistent renal dysfunction, dialysis dependency and mortality at day 90 and 365)<br>• Complications at day 90 and 365 (cerebral insult, cardiovascular diseases, myocardial infarction)<br>• ICU stay and hospital stay