Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
| ThermoFisher Scientific Brahms Biomarkers France | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The prediction and early detection of acute renal failure associated with cardiac surgery (ARF-CS) are desirable in order to try to reduce its magnitude. Indeed, its incidence is high (29 to 36%, reaching up to 81% in some series, depending on the vulnerability of the target population) and its consequences are often serious: prolongation of the length of stay in the intensive care unit and in hospital, death, and evolution towards chronic renal failure, possibly end-stage (justifying long-term extra-renal purification and/or renal transplantation). The challenge is all the more crucial given the high volume of cardiac surgery. In this context, the objective of identifying early on patients at high risk of developing AKI-CC - and therefore eligible for "nephroprotective" measures has generated, in the last decade, a strong interrest around preoperative scores and biomarkers. Thus, more than ten models predicting AKI-CC have been developed and more than 150 candidate biomarkers have been identified since 2004. This insterest is not waning. The DETECT-AKI project aims to evaluate, in a large population (N=400 patients) with varied patient profiles, not only the performance of the most innovative and promising preoperative scores and biomarkers described in the literature, but also the combination of biomarkers with relevant perioperative clinical and biological data in the framework of a clinico-biological score for the early identification of AKI-CC
The DETECT-AKI study aims at establishing an innovative composite score, the basis for decision making in the early initiation of nephroprotection measures. This score will include early clinical and biological data before, during and after surgery and may therefore include one or more modern biomarkers. The DETECT-AKI study foresees from the outset the internal validation of the score by bootstrap method: first essential step for the subsequent application of the established score. This is also one of the strengths of the study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early biomarkers of acute kidney injury | Diagnostic Test | The biomarkers tested will be:
These biomarkers will, if necessary, be corrected for hemodilution or dilution of urine, if any, using [pre-, post-CC, H6] protein and [pre-, post-CC, H6] creatinine, respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| composite score | The primary endpoint will be ASCroc associated with the DETECT-AKI composite score established at H6. AKI-CC will be based on the current international definition (elevation of creatinine and/or occurrence of oliguria within 48 h postoperatively). Internal validation of the score will be based on a bootstrap resampling method. | From pre-CC to 6th hour post CC |
| Measure | Description | Time Frame |
|---|---|---|
| Early renal biomarkers performance (creatininemia, urinary TIMP*IGFBP7, plasma and urinary NGAL, plasma Cystatin C / Plasma Hemolysis Index (PH) / interleukin-6, uremia and urinary DKK3) | Comparison of individual biomarker performance in identifying AKI-CC (all stages) at or before the 6th hour post-CC. The performance of an isolated measurement (at a given perioperative time) of a given biomarker will be analyzed, as well as the variation over time of the concentration of this biomarker (diagnostic performance of the biomarker kinetics). |
Not provided
Inclusion Criteria:
Adults undergoing scheduled, combined, cardiac surgery with CEC.
"Combined" cardiac surgery (as opposed to simple cardiac surgery, which is less likely to result in ARF-CC) involves:
A "scheduled" surgical procedure implies that the patient was added to the operative schedule more than 24 hours before the procedure.
Exclusion Criteria:
Not provided
Not provided
Not provided
Adults undergoing scheduled, combined, cardiac surgery with CC inducing possible acute kidney injury as a consequence
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karim Lakhal, MD | Nantes UH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes UH | Nantes | 44000 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
whole blood and urine
| From pre-CC to 6th hour post CC |
| Score performance of early renal biomarkers (creatininemia, urinary CCL-14, plasma and urinary NGAL, plasma Cystatin C, IH, IL6, angiopoietin-2, PENK-A, uremia and urinary DKK3) | Comparison of the performance of scores proposed in the literature for the prediction of AKI-CC (all stages) on pre-operative data:
| From pre-CC to 6th hour post CC |
| Score and biomarkers performance for prediction | Comparison of the individual performances of scores and biomarkers for the prediction or early detection of moderate to severe AKI-CC (KDIGO stages II and III), rather than AKI-CC of any stage. | From pre-CC to 6th hour post CC |
| Algorithm | Construction of a triage algorithm for early classification of patients according to risk of developing AKI-CC (any stage) with pre-operative data as well as per-operative and early post-operative data | From pre-CC to 6th hour post CC |
| Biomarkers performance in AKI persistance (creatininemia, urinary TIMP*IGFBP7, plasma and urinary NGAL, plasma Cystatin C / Plasma Hemolysis Index (PH) / interleukin-6, uremia and urinary DKK3) | Evaluation of the performance of biomarkers to predict the transient or persistent nature of AKI-CC beyond the 48th hour in patients who have developed AKI-CC. | beyond 48th hour post CC to 7 days |
| Sensitivity analysis | Sensitivity analysis: analysis of the performance of the composite score using
| At 7th days |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |