Clinical, Biological and Histological Pulmonary and Renal... | NCT04385004

Studies
Clinical, Biological and Histological Pulmonary and Renal Damage Associated With the SARS-CoV-2 Syndrome in Patients Admitted in ICU

NCT04385004

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

May 28, 2020Actual

Enrollment

320Estimated

Phase

Not provided

Conditions

Acute Respiratory Distress Syndrome

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 27, 2020Actual

Primary Completion Date

Jul 2020Estimated

Completion Date

Jul 2020Estimated

First Submitted Date

May 8, 2020

First Submission Date that Met QC Criteria

May 8, 2020

First Posted Date

May 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2020

Last Update Posted Date

May 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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)

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

320Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients diagnosed Covid-19 by RT PCR

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ferhat MEZIANI, MD, PhD	Contact	33 3 69 55 10 24		ferhat.meziani@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR	Contact	33 3 88 11 66 90		said.chayer@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service Reanimation Medicale	Recruiting	Strasbourg		67091	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34266454	Derived	Beloncle F, Studer A, Seegers V, Richard JC, Desprez C, Fage N, Merdji H, Pavlovsky B, Helms J, Cunat S, Mortaza S, Demiselle J, Brochard L, Mercat A, Meziani F. Longitudinal changes in compliance, oxygenation and ventilatory ratio in COVID-19 versus non-COVID-19 pulmonary acute respiratory distress syndrome. Crit Care. 2021 Jul 15;25(1):248. doi: 10.1186/s13054-021-03665-8.

ID	Term
D012128	Respiratory Distress Syndrome
D000086382	COVID-19
D018805	Sepsis
D007511	Ischemia

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders
D011024	Pneumonia, Viral