Cardiovascular and Renal Biomarkers to Predict Acute Heart or Kidney Injury in Severe Covid-19 Infection (Nancy-CovH-AKI)

Central Hospital, Nancy, France

Status: Completed

Conditions: COVID 19

Treatments: Procedure: Telephone follow-up; Procedure: Clinical examination; Procedure: Biological samples specific to research

Study type: Interventional

Funder types: Other

Identifiers

NCT04354610

2020PI072

Details and patient eligibility

About

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

Full description

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 /)

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 1 patient group

Patients hospitalized for Covid-19 infection

Other group

Description:

Patients hospitalized for Covid-19 infection will undergo the following evaluations: * Clinical examination * Blood sample retrieved for biological assessment and biobanking * Telephone interview

Treatment:

Procedure: Telephone follow-up

Procedure: Clinical examination

Procedure: Biological samples specific to research