Cardiovascular and Renal Biomarkers to Predict Acute Heart or Kidney Injury in Severe Covid-19 Infection

NCT ID: NCT04354610

Last Updated: 2021-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-27
• Study Completion Date: 2021-03-26

Brief Summary

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

Detailed 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 /)

Conditions

COVID 19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients hospitalized for Covid-19 infection

Patients hospitalized for Covid-19 infection will undergo the following evaluations:

• Clinical examination
• Blood sample retrieved for biological assessment and biobanking
• Telephone interview

Group Type: OTHER

Biological samples specific to research

Intervention Type: PROCEDURE

Blood samples, saliva collection, and urine collection to carry out biomarker assays and for the constitution of a biological collection.

Clinical examination

Intervention Type: PROCEDURE

Clinical examination

Telephone follow-up

Intervention Type: PROCEDURE

Telephone follow-up at 3 months after discharge from hospital

Interventions

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.

Intervention Type: PROCEDURE

Clinical examination

Clinical examination

Intervention Type: PROCEDURE

Telephone follow-up

Telephone follow-up at 3 months after discharge from hospital

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Pr Patrick ROSSIGNOL

Prediction of Acute Heart or Kidney Injury With Cardiovascular-renal Biomarkers in Patients Hospitalised for Severe or Critical Covid-19 Infection

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHRU de Nancy

Nancy, , France

CHRU de Nancy

Vandœuvre-lès-Nancy, , France

Countries

France

Other Identifiers

2020PI072

Identifier Type: -

Identifier Source: org_study_id