Skip to main content
Clinical Trials/NCT05077982
NCT05077982
Completed
Not Applicable

Long Term Outcomes of COVID-19 Critical Illness: Cohort Study of Adult Patients Admitted to the Intensive Care Unit at Mater Dei Hospital With COVID-19 Infection

Sciberras, Stephen M.D.1 site in 1 country123 target enrollmentOctober 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Covid19
Sponsor
Sciberras, Stephen M.D.
Enrollment
123
Locations
1
Primary Endpoint
Long term general health effects of critical illness due to COVID-19 infection
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

An observational cohort study of patients discharged from the ICU following admission with COVID19 infection, looking at their medical wellbeing 6 months after discharge from the ICU.

Detailed Description

The COVID-19 epidemic has placed an unprecedented strain on medical services worldwide. Throughout 2020 and early 2021, hospitals and their critical care services have been inundated with patients suffering from critical illness due to COVID-19, some of whom developed multi-organ failure and required a prolonged ICU stay. While the medical literature is now replete with publications and research on the acute phase of illness due to COVID-19, including critical illness, there is a paucity of studies detailing the long-term outcomes following COVID-19 critical illness. While the negative long-term physical health, mental health and quality-of-life related effects of ARDS have been well documented, there has been very little long-term COVID-19 ARDS specific outcome studies published. This is an observational cohort study that aims to assess the long-term health outcomes of adult patients admitted to Mater Dei Hospital Intensive Care Unit with COVID-19 infection. Patients will initially be assessed at 6 months after discharge from ITU. They will be interviewed by trained researchers using validated questionnaires. These questionnaires will assess their physical health, mental health and functional status. Participants will be examined and asked to do a 6minute walk test also using validated non-invasive physical assessment tools. They will be offered pulmonary function tests to be carried out at the Pulmonary function laboratory.

Registry
clinicaltrials.gov
Start Date
October 15, 2021
End Date
January 31, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sciberras, Stephen M.D.
Responsible Party
Principal Investigator
Principal Investigator

Stephen Sciberras

Supervisor

Sciberras, Stephen M.D.

Eligibility Criteria

Inclusion Criteria

  • All patients admitted to the Intensive Care Unit with organ failure secondary to acute COVID-19 infection and successfully discharged from Mater Dei Hospital and surviving beyond 6 months after discharge, will be offered inclusion in the study.
  • A positive COVID PCR result before or during the patient's admission will be necessary for inclusion in the study. Participants will be over 18 years of age, with no restriction as regards race, ethnicity or gender.

Exclusion Criteria

  • There are no exclusion criteria

Outcomes

Primary Outcomes

Long term general health effects of critical illness due to COVID-19 infection

Time Frame: at 12 months

Observation of the effect critical illness due to COVID-19 has on a patients' health related quality of life at 6 and 12 months after discharge from the ICU

Secondary Outcomes

  • Correlation between severity of COVID19 illness and QOL(at 12 months)

Study Sites (1)

Loading locations...

Similar Trials