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NCT Number: NCT04838106

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Covid19 Brain Diseases COVID-19 Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coronaviridae Infections Coronavirus Infections Critical Illness Deep Vein Thrombosis Disease Attributes Embolism Embolism and Thrombosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Infarction Infections Ischemia Kidney Diseases Lung Diseases Male Urogenital Diseases Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Pulmonary Embolism RNA Virus Infections Renal Failure Renal Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Stroke Thrombosis Urogenital Diseases Urologic Diseases Vascular Diseases Venous Thrombosis Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Critical Care Research Group, Nuffield Department of Clinical Neurosciences, University of Oxford

Oxford, Oxfordshire, OX3 9DU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Not applicable as observational study

Other

Not applicable as observational study.

Primary outcomes

  1. Mortality Rate

    Time frame: One year

    Mortality after discharge from hospital

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Intensive Care National Audit & Research Centre

Registry information

Official study 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)

Acronym: OPTIC-19

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2021
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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