Outcomes of Patients Who Survived Treatment on an Intensive Care Unit for COVID-19 in England and Wales (OPTIC-19)

August 13, 2024 updated by: University of Oxford

Outcomes of Patients Who Survived Treatment on an Intensive Care Unit for COVID-19 in England and Wales: a Comparative Retrospective Cohort Study (OPTIC-19)

This retrospective cohort study aims to characterise outcomes for patients treated on an intensive care unit (ICU) with COVID-19 in England and Wales, one year after discharge from hospital. Outcomes will be compared with patients admitted as an emergency to an ICU for other conditions. The study will use existing national audit data linked to routine healthcare datasets.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Across England and Wales, over 10,000 patients have been treated for severe coronavirus disease 2019 (COVID-19) on an intensive care unit. Around 60% survived to leave hospital. It is unknown how survivors' severe COVID-19 infection, or the treatment they received on the intensive care unit, will affect their long-term health. Understanding what happens to these patients can help ensure they receive suitable care from their General Practitioner (GP) and other National Health Service (NHS) services after they leave hospital.

This study will follow up survivors for 1 year after discharge from hospital. The investigators will use data collected by the Intensive Care National Audit and Research Centre (ICNARC) to identify patients who were treated on an ICU for COVID-19. The investigators will then use NHS data to see whether these patients were readmitted to hospital and why. Information from the Office of National Statistics will identify whether patients died. By linking different sources of patient data, the investigators will estimate the health risks faced by survivors of severe COVID-19. These risks will be compared to those in patients treated on an ICU for other conditions.

Study Type

Observational

Enrollment (Estimated)

319600

Contacts and Locations

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

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Critical Care Research Group, Nuffield Department of Clinical Neurosciences, University of Oxford

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to an adult (16 years or over), general ICU in England or Wales as an emergency between 1st July 2016 and 1st July 2020 who survived to hospital discharge.

Description

Inclusion Criteria:

  • Age 16 years or over
  • Admitted to an adult, general ICU in England or Wales as an emergency (unplanned)
  • Admitted to ICU for either: a) confirmed COVID-19 between 1st January to 1st July 2020 or b) without confirmed COVID-19 between 1st July 2016 and 1st July 2020-

Exclusion Criteria:

  • Patients who died in hospital after treatment on an ICU

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: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Covid19
Patients admitted to an adult (16 years or over), general ICU in England or Wales as an emergency with confirmed COVID-19 between 1st January to 1st July 2020.
Other: Not applicable as observational study
Not applicable as observational study.
Non Covid19
Patients admitted to an adult (16 years or over), general ICU in England or Wales as an emergency without confirmed COVID-19 between 1st July 2016 and 1st July 2020.
Other: Not applicable as observational study
Not applicable as observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality Rate
Time Frame: One year
Mortality after discharge from hospital
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of emergency hospital admission
Time Frame: one year
Emergency hospital admission
one year
Rate of emergency hospital admission for respiratory infection
Time Frame: one year
Emergency hospital admission for respiratory infection
one year
Rate of emergency hospital admission for a major adverse cardiac event
Time Frame: one year
Emergency hospital admission for a major adverse cardiac event (myocardial infarction, stroke, heart failure)
one year
Rate of emergency hospital admission for a venous thrombotic event
Time Frame: one year
Emergency hospital admission for a venous thrombotic event (deep vein thrombosis or pulmonary embolism)
one year
Rate of development of end stage renal failure
Time Frame: one year
Development of end stage renal failure treated by renal replacement therapy
one year

Collaborators and Investigators

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

Sponsor

University of Oxford

Collaborators

Intensive Care National Audit & Research Centre

Investigators

  • Principal Investigator: Peter Watkinson, MD, University of Oxford

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)

August 1, 2020

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

August 14, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PID15456
  • 21/SC/0021 (Other Identifier: South Central - Hampshire B Research Ethics Committee)
  • 21/CAG/0017 (Other Identifier: Confidentiality Advisory Group)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made publicly available due to privacy and legal implications.

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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