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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04838106
Recruitment Status : Active, not recruiting
First Posted : April 8, 2021
Last Update Posted : January 6, 2022
Sponsor:
Collaborator:
Intensive Care National Audit & Research Centre
Information provided by (Responsible Party):
University of Oxford

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Covid19 Myocardial Infarction Stroke Critical Illness Heart Failure Deep Vein Thrombosis Pulmonary Embolism Renal Failure Other: Not applicable as observational study

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 Design
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Study Type : Observational
Estimated Enrollment : 319600 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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)
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Mortality Rate [ Time Frame: One year ]
    Mortality after discharge from hospital


Secondary Outcome Measures :
  1. Rate of emergency hospital admission [ Time Frame: one year ]
    Emergency hospital admission

  2. Rate of emergency hospital admission for respiratory infection [ Time Frame: one year ]
    Emergency hospital admission for respiratory infection

  3. 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)

  4. 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)

  5. Rate of development of end stage renal failure [ Time Frame: one year ]
    Development of end stage renal failure treated by renal replacement therapy


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04838106


Locations
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United Kingdom
Critical Care Research Group, Nuffield Department of Clinical Neurosciences, University of Oxford
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Sponsors and Collaborators
University of Oxford
Intensive Care National Audit & Research Centre
Investigators
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Principal Investigator: Peter Watkinson, MD University of Oxford
More Information
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT04838106    
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 )
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: January 6, 2022
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be made publicly available due to privacy and legal implications.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pulmonary Embolism
Myocardial Infarction
Thrombosis
Embolism
Venous Thrombosis
Infarction
Critical Illness
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Embolism and Thrombosis
Disease Attributes