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NCT Number: NCT04354610

Cardiovascular and Renal Biomarkers to Predict Acute Heart or Kidney Injury in Severe 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nancy, Nancy, France

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About this study

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 /)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biological samples specific to research

Procedure

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

Clinical examination

Procedure

Clinical examination

Telephone follow-up

Procedure

Telephone follow-up at 3 months after discharge from hospital

Primary outcomes

  1. Worsening of renal function by at least KDIGO grade 1 during hospitalization for Covid-19 infection

    Time frame: From inclusion to hospital discharge, an average of 21 days

    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).

  2. Troponin greater than 99th percentile during hospitalization for Covid-19 infection

    Time frame: From inclusion to hospital discharge, an average of 21 days

    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 outcomes

  1. AKI KDIGO grade 1 or higher in hospitalisation (approach with AND without a priori)

    Time frame: From inclusion to hospital discharge, an average of 21 days

    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 )

  2. Elevation of troponin> 99th percentile in hospitalisation (approach with AND without a priori)

    Time frame: From inclusion to hospital discharge, an average of 21 days

    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)

  3. AKI KDIGO grade 1 or higher

    Time frame: From inclusion to hospital discharge, an average of 21 days

    AKI KDIGO grade 1 in hospitalisation

  4. Association with troponin elevation >99th

    Time frame: From inclusion to hospital discharge, an average of 21 days

    Association with troponin elevation >99th percentile during hospitalisation

  5. Association with elevation of serum creatinine >30%

    Time frame: From inclusion to hospital discharge, an average of 21 days

    Association with elevation of serum creatinine >30% during hospitalisation

  6. With the onset of chronic renal failure (eDFG <60 ml / min / 1.73m2)

    Time frame: 3 months after discharge from hospital

    With the onset of chronic renal failure (eDFG <60 ml / min / 1.73m2) three months after discharge from hospital

  7. The occurrence of cardiovascular events (stroke, myocardial infarction, hospitalisation for heart failure, cardiovascular death) during hospitalisation and three months after discharge from hospital

    Time frame: From inclusion to 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

  8. The occurrence of death from any cause during hospitalisation and three months after discharge from hospital

    Time frame: From inclusion to 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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: Nancy-CovH-AKI

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Apr 21, 2020
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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