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

Primary Purpose

COVID 19

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological samples specific to research
Clinical examination
Telephone follow-up
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COVID 19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHRU de Nancy
  • CHRU de Nancy

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients hospitalized for Covid-19 infection

Arm Description

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

Outcomes

Primary Outcome Measures

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).
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)

Secondary Outcome Measures

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 )
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)
AKI KDIGO grade 1 or higher
AKI KDIGO grade 1 in hospitalisation
Association with troponin elevation >99th
Association with troponin elevation >99th percentile during hospitalisation
Association with elevation of serum creatinine >30%
Association with elevation of serum creatinine >30% during hospitalisation
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
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
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

Full Information

First Posted
April 14, 2020
Last Updated
September 30, 2021
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT04354610
Brief Title
Cardiovascular and Renal Biomarkers to Predict Acute Heart or Kidney Injury in Severe Covid-19 Infection
Acronym
Nancy-CovH-AKI
Official Title
Prediction of Acute Heart or Kidney Injury With Cardiovascular-renal Biomarkers in Patients Hospitalised for Severe or Critical Covid-19 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 27, 2020 (Actual)
Primary Completion Date
December 19, 2020 (Actual)
Study Completion Date
March 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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 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 /)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID 19

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients hospitalized for Covid-19 infection
Arm Type
Other
Arm Description
Patients hospitalized for Covid-19 infection will undergo the following evaluations: Clinical examination Blood sample retrieved for biological assessment and biobanking Telephone interview
Intervention Type
Procedure
Intervention Name(s)
Biological samples specific to research
Intervention Description
Blood samples, saliva collection, and urine collection to carry out biomarker assays and for the constitution of a biological collection.
Intervention Type
Procedure
Intervention Name(s)
Clinical examination
Intervention Description
Clinical examination
Intervention Type
Procedure
Intervention Name(s)
Telephone follow-up
Intervention Description
Telephone follow-up at 3 months after discharge from hospital
Primary Outcome Measure Information:
Title
Worsening of renal function by at least KDIGO grade 1 during hospitalization for Covid-19 infection
Description
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).
Time Frame
From inclusion to hospital discharge, an average of 21 days
Title
Troponin greater than 99th percentile during hospitalization for Covid-19 infection
Description
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)
Time Frame
From inclusion to hospital discharge, an average of 21 days
Secondary Outcome Measure Information:
Title
AKI KDIGO grade 1 or higher in hospitalisation (approach with AND without a priori)
Description
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 )
Time Frame
From inclusion to hospital discharge, an average of 21 days
Title
Elevation of troponin> 99th percentile in hospitalisation (approach with AND without a priori)
Description
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)
Time Frame
From inclusion to hospital discharge, an average of 21 days
Title
AKI KDIGO grade 1 or higher
Description
AKI KDIGO grade 1 in hospitalisation
Time Frame
From inclusion to hospital discharge, an average of 21 days
Title
Association with troponin elevation >99th
Description
Association with troponin elevation >99th percentile during hospitalisation
Time Frame
From inclusion to hospital discharge, an average of 21 days
Title
Association with elevation of serum creatinine >30%
Description
Association with elevation of serum creatinine >30% during hospitalisation
Time Frame
From inclusion to hospital discharge, an average of 21 days
Title
With the onset of chronic renal failure (eDFG <60 ml / min / 1.73m2)
Description
With the onset of chronic renal failure (eDFG <60 ml / min / 1.73m2) three months after discharge from hospital
Time Frame
3 months after discharge from hospital
Title
The occurrence of cardiovascular events (stroke, myocardial infarction, hospitalisation for heart failure, cardiovascular death) during hospitalisation and three months after discharge from hospital
Description
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
Time Frame
From inclusion to three months after discharge from hospital
Title
The occurrence of death from any cause during hospitalisation and three months after discharge from hospital
Description
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
Time Frame
From inclusion to three months after discharge from hospital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
CHRU de Nancy
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
CHRU de Nancy
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54500
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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