Biological samples specific to research
ProcedureBlood samples, saliva collection, and urine collection to carry out biomarker assays and for the constitution of a biological collection.
NCT Number: NCT04354610
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
CHRU de Nancy, Nancy, France
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exclusion criterion for patients taking part in clinical research.
Blood samples, saliva collection, and urine collection to carry out biomarker assays and for the constitution of a biological collection.
Clinical examination
Telephone follow-up at 3 months after discharge from hospital
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).
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)
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 )
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)
Time frame: From inclusion to hospital discharge, an average of 21 days
AKI KDIGO grade 1 in hospitalisation
Time frame: From inclusion to hospital discharge, an average of 21 days
Association with troponin elevation >99th percentile during hospitalisation
Time frame: From inclusion to hospital discharge, an average of 21 days
Association with elevation of serum creatinine >30% during hospitalisation
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
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
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
Central Hospital, Nancy, France
Other
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
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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