Is Precariousness a Risk Factor for COVID-19 Mortality in Intensive Care?

NCT04896944 | Completed

• 1 other identifier: Centre Hospitalier Saint Denis
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Is precariousness a risk factor for COVID-19 mortality in intensive care units ? Abstract Background: During the SARS-CoV-2 pandemic, the first wave overwhelmed hospitals in Paris area (Ile-de-France) with a variable impact depending on the territory. Several studies highlighted variable ICU mortality rates during COVID-19 surges across territories (10 to 60%) with higher rates in those most affected by poverty. We assessed the impact of precariousness, as an independent risk factor, on mortality linked to Covid-19 between ICUs at Delafontaine hospital and Ambroise Paré hospital. Method: Investigators carry out a retrospective observational cohort study of consecutive ICU patients aged ≥ 18 years admitted at Delafontaine and Ambroise Paré hospitals during the first wave of the Covid-19 outbreak in order to compare mortality rates according to predefined risk factors (age, diabetes, arterial hypertension, BMI, active solid or haematological cancer, IGS2, poverty rate at the threshold of 60% (%) according to the island grouped for statistical information (IRIS)37 of the patient, invasive ventilation or not) that include precariousness. Results: Conclusion:

Conditions

Precariousness; Critically Ill; Covid19

Outcome Measures

Primary Outcomes (1)

• Death

  90 days

Secondary Outcomes (3)

• Death in ICU

  90 days

• ICU length of stay

  6 months

• Hospital length of stay

  6 months

Study Arms (2)

ICU Centre Hospitalier de Saint Denis

Other: No intervention

ICU Hôpital Ambroise Paré Boulogne

Other: No intervention

Interventions

No intervention OTHER

No intervention

ICU Centre Hospitalier de Saint Denis; ICU Hôpital Ambroise Paré Boulogne

Eligibility Criteria

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

Study Population

Patient admitted in ICU for COVID-19 critical illness

You may qualify if:

• all patients hospitalized in intensive care at Delafontaine hospital (12 intensive care beds and 6 CCU beds) and Ambroise Paré hospital (12 intensive care beds and 6 CCU beds) that has developed a Covid-19 pneumonitis confirmed biologically by nasopharyngeal PCR or on deep respiratory samples (bronchial, tracheal aspiration or bronchoalveolar lavage) or strongly suspected with a compatible CT27 and a very evocative clinical history depending on the practitioner in charge would be included into the study.

You may not qualify if:

• all minor patients under the age of 18 and patients transferred after less than 24 hours of care in the service would be excluded.

Sponsors & Collaborators

• Centre Hospitalier de Saint-Denis: lead

Study Sites (1)

Centre Hospitalier de Saint Denis

Saint-Denis, 93200, France

Location

MeSH Terms

Conditions

Critical Illness; COVID-19

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Laurent Lainé

  laurent.laine@ch-stdenis.fr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 21, 2021
• Study Start: March 13, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: May 31, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

FR (1)