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:
1. AKI KDIGO grade 1 or higher or elevation of troponin >99th percentile in hospitalisation
(approach with AND without a priori)
2. AKI KDIGO grade 1 or higher
3. Elevation of troponin >99th percentile in hospitalisation
4. Elevated serum creatinine >30% in hospital
5. Chronic renal failure (eDFG <60 ml / min / 1.73m2) three months after discharge from
hospital
6. Cardiovascular events (stroke, myocardial infarction, hospitalization for heart failure,
cardiovascular death) and mortality in hospital and at three months after discharge from
hospital
7. Considering future exploratory analyses (biological collection of plasma, serum, saliva,
urine, viruses) (for example other OLINK panels) on the previous endpoints
- NGAL (Neutrophil Gelatinase Associated Lipocalin), Cystatin C, Kidney Injury
Molecule-1 (Kim-1), ACE-2, renin, Brain-type Natriuretic Peptide (BNP),
Adrenomedullin, FGF (fibroblast growth factor-23 are all included in the 2 Olink
panels "CVDII" (https://www.olink.com/products/cvd-ii-panel/: listing) and
"cardiometabolic" (https://www.olink.com/products/cardiometabolic-panel /)
Procedure: Biological samples specific to research
Blood samples, saliva collection, and urine collection to carry out biomarker assays and for the constitution of a biological collection.
Procedure: Clinical examination
Clinical examination
Procedure: Telephone follow-up
Telephone follow-up at 3 months after discharge from hospital
Inclusion Criteria:
- Patients over the age of 18,
- Admission for less than 3 days in the medical service (or in intensive care) for
proven serious form of Covid 19 infection (respiratory rate >30 / min, or desaturation
in air ≤ 93%, or PaO2 / FiO2 ≤ 300mmHg)
- OR Admission for less than 2 days in intensive care (or resuscitation intensive care)
for critical form of Covid 19 (shock or respiratory failure).
- GFR greater than 30 ml / min / 1.73m2.
- Troponin <99th percentile.
- Patient affiliated to a social security scheme or beneficiary of such a scheme
- The patient or their representative received complete information on the study and
signed and dated the emergency situation informed consent/inclusion form in accordance
with article L1122-1-3 of the French Public Health Code (Code de la Santé Publique).
Exclusion Criteria:
Exclusion criterion for patients taking part in clinical research.
- AKI KDIGO grade 1 on the day of visit 1
- Pregnant women, parturient, or nursing mothers
- A person of full age subject to a legal protection measure (guardianship, curatorship,
safeguard of justice)
- Person deprived of their liberty by a judicial or administrative decision,
- Person undergoing psychiatric treatment under articles L. 3212-1 and L. 3213-1 of the
Public Health Code.
CHRU de Nancy
Nancy, France
CHRU de Nancy
Vandœuvre-lès-Nancy, France