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

NCT04354610 | Completed

• 1 other identifier: 2020PI072
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

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

Conditions

COVID 19

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

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

  From inclusion to hospital discharge, an average of 21 days

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

  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

• Association with elevation of serum creatinine >30%

  From inclusion to hospital discharge, an average of 21 days

Study Arms (1)

Patients hospitalized for Covid-19 infection

OTHER

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; Procedure: Clinical examination; Procedure: Telephone follow-up

Interventions

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.

Patients hospitalized for Covid-19 infection

Clinical examination PROCEDURE

Clinical examination

Patients hospitalized for Covid-19 infection

Telephone follow-up PROCEDURE

Telephone follow-up at 3 months after discharge from hospital

Patients hospitalized for Covid-19 infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (2)

CHRU de Nancy

Nancy, 54000, France

Location

CHRU de Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prediction of Acute Heart or Kidney Injury With Cardiovascular-renal Biomarkers in Patients Hospitalised for Severe or Critical Covid-19 Infection

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 21, 2020
• Study Start: April 27, 2020
• Primary Completion: December 19, 2020
• Study Completion: March 26, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-01

Locations

FR (2)