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The Nancy Cov-H-AKI: study is a prospective, non-randomized, monocenter study performed in patients hospitalised for either the severe or the critical form of Covid-19.
The main objective of the Nancy Cov-H-AKI study is to evaluate the association of variations (from inclusion to 72H post-inclusion) of 5 blood-based cardio-vascular-renal biomarkers selected a priori, cardiac (NT-proBNP), coagulation (D-dimers), related to the renin angiotensin aldosterone system (ACE2) and renal (Penkid, and NGAL) with the appearance of acute kidney injury KDIGO grade 1 or higher OR cardiac injury in patients hospitalised for either the severe or the critical form of Covid-19
Secondary objectives
Evaluate the association of the concentrations at inclusion AND of the variations (between inclusion and 72H post-inclusion) of blood and urine cardiovascular-renal biomarkers of interest (selected a priori: cardiac (NT-proBNP, (bio)-Adrenomedullin), coagulation (D-dimers), linked to the renin angiotensin aldosterone system (renin, ACE2, Angiotensin 2), inflammatory (ceramides), oxidative stress, and renal (PENKID, cystatin C) and renal glomerulo-tubulopathy ( renal functional exploration in blood and urine, and AKI (blood (NGAL, KIM-1) and urinary (IGFBP7-TIMP2)) biomarkers, AND WITHOUT a priori by an analysis of 184 blood protein biomarkers in connection with cardiovascular and inflammatory damage * ) with the appearance of:
AKI KDIGO grade 1 or higher or elevation of troponin >99th percentile in hospitalisation (approach with AND without a priori)
AKI KDIGO grade 1 or higher
Elevation of troponin >99th percentile in hospitalisation
Elevated serum creatinine >30% in hospital
Chronic renal failure (eDFG <60 ml / min / 1.73m2) three months after discharge from hospital
Cardiovascular events (stroke, myocardial infarction, hospitalization for heart failure, cardiovascular death) and mortality in hospital and at three months after discharge from hospital
Considering future exploratory analyses (biological collection of plasma, serum, saliva, urine, viruses) (for example other OLINK panels) on the previous endpoints
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients hospitalized for Covid-19 infection | Other | Patients hospitalized for Covid-19 infection will undergo the following evaluations:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological samples specific to research | Procedure | Blood samples, saliva collection, and urine collection to carry out biomarker assays and for the constitution of a biological collection. |
| Measure | Description | Time Frame |
|---|---|---|
| Worsening of renal function by at least KDIGO grade 1 during hospitalization for Covid-19 infection | Composite endpoint : Worsening of renal function by at least KDIGO grade 1 criteria from inclusion visit OR troponin greater than 99th percentile during hospitalization for Covid-19 infection (with Outcome 2). | From inclusion to hospital discharge, an average of 21 days |
| Troponin greater than 99th percentile during hospitalization for Covid-19 infection | Composite endpoint : Worsening of renal function by at least KDIGO grade 1 criteria from inclusion visit OR troponin greater than 99th percentile during hospitalization for Covid-19 infection (with Outcome 1) | From inclusion to hospital discharge, an average of 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| AKI KDIGO grade 1 or higher in hospitalisation (approach with AND without a priori) | Composite endpoint : AKI KDIGO grade 1 or higher or Elevation of troponin> 99th percentile in hospitalisation (approach with AND without a priori) ((with Outcome 3 ) | From inclusion to hospital discharge, an average of 21 days |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criterion for patients taking part in clinical research.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Nancy | Nancy | 54000 | France | |||
| CHRU de Nancy |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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| Clinical examination | Procedure | Clinical examination |
|
| Telephone follow-up | Procedure | Telephone follow-up at 3 months after discharge from hospital |
|
| Elevation of troponin> 99th percentile in hospitalisation (approach with AND without a priori) |
Composite endpoint : AKI KDIGO grade 1 or higher or Elevation of troponin> 99th percentile in hospitalisation (approach with AND without a priori) (with Outcome 3) |
| From inclusion to hospital discharge, an average of 21 days |
| AKI KDIGO grade 1 or higher | AKI KDIGO grade 1 in hospitalisation | From inclusion to hospital discharge, an average of 21 days |
| Association with troponin elevation >99th | Association with troponin elevation >99th percentile during hospitalisation | From inclusion to hospital discharge, an average of 21 days |
| Association with elevation of serum creatinine >30% | Association with elevation of serum creatinine >30% during hospitalisation | From inclusion to hospital discharge, an average of 21 days |
| With the onset of chronic renal failure (eDFG <60 ml / min / 1.73m2) | With the onset of chronic renal failure (eDFG <60 ml / min / 1.73m2) three months after discharge from hospital | 3 months after discharge from hospital |
| The occurrence of cardiovascular events (stroke, myocardial infarction, hospitalisation for heart failure, cardiovascular death) during hospitalisation and three months after discharge from hospital | Composite outcome : the occurrence of cardiovascular events (stroke, myocardial infarction, hospitalisation for heart failure, cardiovascular death) and death from any cause during hospitalisation and three months after discharge from hospital | From inclusion to three months after discharge from hospital |
| The occurrence of death from any cause during hospitalisation and three months after discharge from hospital | Composite outcome : the occurrence of cardiovascular events (stroke, myocardial infarction, hospitalisation for heart failure, cardiovascular death) and death from any cause during hospitalisation and three months after discharge from hospital | From inclusion to three months after discharge from hospital |
| Vandœuvre-lès-Nancy |
| 54500 |
| France |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |