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

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

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

Study Overview

• Status: Completed
• Conditions: COVID 19
• Intervention / Treatment: Procedure: Biological samples specific to research; Procedure: Clinical examination; Procedure: Telephone follow-up

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 /)

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • CHRU de Nancy
  • Vandœuvre-lès-Nancy, France, 54500
    • CHRU de Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2020
• Primary Completion (Actual): December 19, 2020
• Study Completion (Actual): March 26, 2021

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020PI072

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No