Clinical, Biological and Histological Pulmonary and Renal Damage Associated With the SARS-CoV-2 Syndrome in Patients Admitted in ICU (PR-Covid-19)

May 26, 2020 updated by: University Hospital, Strasbourg, France

Characterization of the Clinical, Biological and Histological Pulmonary and Renal Damage Associated With the SARS-CoV-2 Syndrome in Patients Admitted in the Intensive Care Unit

Renal damage in patients hospitalized for ARDS in the ICU can also be related to multiple causes including, but not limited to, the consequences of hemodynamic fluctuations in these patients or the use of nephrotoxic drugs responsible for acute post-ischemic or toxic tubular necrosis. Frequently observed abnormalities of cioagumation may also have a potential impact on renal structures, particularly glomerular capillaries.

The researchers wish to characterize and phenotype the renal impairment of patients hospitalized in intensive care with tables of severe Covid19 infections in ARDS: clinical, biological and histological (by performing post-mortem biopsies).

Translated with www.DeepL.com/Translator (free version)

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service Reanimation Medicale
        • Contact:
        • Principal Investigator:
          • Ferhat MEZIANI, MD, PhD
        • Sub-Investigator:
          • Bruno MOULIN, MD, PhD
        • Sub-Investigator:
          • Sophie CAILLARD, MD, PhD
        • Sub-Investigator:
          • Francis SCHNEIDER, MD, PhD
        • Sub-Investigator:
          • Michel MERTES, MD, PhD
        • Sub-Investigator:
          • Patrick OHLMANN, MD, PhD
        • Sub-Investigator:
          • Julie HELMS, MD
        • Sub-Investigator:
          • Romain KESSLER, MD, PhD
        • Sub-Investigator:
          • Alexandra Monnier, MD
        • Sub-Investigator:
          • Hamid MERDJI, MD
        • Sub-Investigator:
          • Margaux DELLA CHIESA, MD
        • Sub-Investigator:
          • François SEVERAC, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients diagnosed Covid-19 by RT PCR

Description

Inclusion Criteria:

  • Patients over 18 years of age
  • Diagnosed Covid-19 by RT PCR
  • Hospitalized in intensive care for management of complications related to Covid-19 from March 1, 2020 to April 20, 2020
  • Patient not having expressed his or her opposition, after information, to the re-use of his or her data for the purposes of this research.

Exclusion Criteria:

- Subject who expressed opposition to participating in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Analysis of Clinical, Biological and Histological Pulmonary and Renal Impairment Related to SARS-CoV-2
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2020

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

May 8, 2020

First Submitted That Met QC Criteria

May 8, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Actual)

May 28, 2020

Last Update Submitted That Met QC Criteria

May 26, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7815 (CTEP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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