Prediction of Acute Heart or Kidney Injury With Cardiovascular-renal Biomarkers in Patients Hospitalised for Severe or Critical Covid-19 Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Troponin greater than 99th percentile during hospitalization for Covid-19 infection
研究概览
简要总结
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
详细描述
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 /)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 / 1.73m
- •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).
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Biological samples specific to research (Procedure)
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
干预措施: Clinical examination (Procedure)
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
干预措施: Telephone follow-up (Procedure)
结局指标
主要结局
Troponin greater than 99th percentile during hospitalization for Covid-19 infection
时间窗: 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)
Worsening of renal function by at least KDIGO grade 1 during hospitalization for Covid-19 infection
时间窗: 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).
次要结局
- AKI KDIGO grade 1 or higher in hospitalisation (approach with AND without a priori)(From inclusion to hospital discharge, an average of 21 days)
- Association with elevation of serum creatinine >30%(From inclusion to hospital discharge, an average of 21 days)
- AKI KDIGO grade 1 or higher(From inclusion to hospital discharge, an average of 21 days)
- Association with troponin elevation >99th(From inclusion to hospital discharge, an average of 21 days)
- With the onset of chronic renal failure (eDFG <60 ml / min / 1.73m2)(3 months after discharge from hospital)
- Elevation of troponin> 99th percentile in hospitalisation (approach with AND without a priori)(From inclusion to hospital discharge, an average of 21 days)
- The occurrence of 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 cardiovascular events (stroke, myocardial infarction, hospitalisation for heart failure, cardiovascular death) during hospitalisation and three months after discharge from hospital(From inclusion to three months after discharge from hospital)
研究者
Pr Patrick ROSSIGNOL
Prediction of Acute Heart or Kidney Injury With Cardiovascular-renal Biomarkers in Patients Hospitalised for Severe or Critical Covid-19 Infection
Central Hospital, Nancy, France