Entry criteria

Who do I recruit?

Please aim to recruit from every eligible group detailed below

We realise you may not be able to recruit every eligible patient so if you do need to prioritise, please start with the youngest patients who are ventilated in your ICU.

If you have time and capacity, we also include a broader range of patients in critical care:

  • Our aim is to capture ICU and HDU patients.
  • Please try to recruit at the earliest opportunity because this offers the greatest chance of recruiting the sickest patients who sadly may not survive.
  • If a patient meets the inclusion criteria they remain eligible for recruitment for the rest of their lives, even after being transferred out of ICU.
  • This means we can also follow up recruitment once a patient has stepped down onto the ward or retrospectively once discharged home.

Entry Criteria

The entry criteria below are approved for use in the UK:

22nd April 2022 v3.0

Inclusion criteria

Inclusion criteria are stratified to facilitate recruitment under conditions in which resources are limited (Dunning et al. 2014). Lower tiers include syndromes with a high probability of genetic susceptibility and will be prioritised in resource-limited settings. Higher tiers describe less-specific syndromes with a focus on mortality.

Patients will be recruited who:

  • Are deemed, in the view of the treating physician, to require continuous cardiovascular or respiratory monitoring or invasive mechanical ventilation,

  • AND provide appropriate consent or assent,

  • AND present with one of the following primary diagnoses:

Group 1: specific infectious syndromes in highly-selected patients

  • COVID-19. Confirmed or suspected COVID-19.

  • Influenza. Confirmed or suspected infection with influenza virus.

  • Secondary pneumonia. Acute pneumonia complicating confirmed infection with influenza virus.

  • Dengue. Confirmed or suspected infection with dengue virus.

  • RSV. Confirmed infection with respiratory syncytial virus.

  • Emerging infections. Confirmed or suspected infection with an emerging infection (see below).

  • Group 2: specific non-infectious critical illness syndromes

    • Burns. Full thickness burns covering  > 20% of body surface area.

    • Emerging critical illness syndromes. Confirmed or suspected presence of an emerging critical illness syndrome. These are unexplained or idiosyncratic presentations of acute organ injury, or suspected reactions to therapeutic agents, including:

      • confirmed or suspected multisystem inflammatory syndrome temporally associated with COVID-19

      • acute disease associated with inhalation of noxious substances or vapours, such as "vaping"

      • acute disease associated with CAR T-cell therapy

    Group 3: extreme critical illness

    • Extra-corporeal life support. Requirement for continuous veno-venous extra-corporeal support for respiratory failure of any aetiology.

    Group 4: common/nonspecific critical illness syndromes

    • Cellulitis. Soft tissue infections causing systemic sepsis.

    • Pneumonia. Primary pneumonia of any aetiology, with radiographic changes at presentation to critical care. Pneumonia is defined as: symptoms and signs consistent with an acute lower respiratory tract infection associated with new radiographic shadowing for which there is no other explanation (eg, not pulmonary oedema or infarction). Where this illness is the primary reason for hospital admission and is managed as pneumonia, the patient is eligible for inclusion.(Harris et al, 2011) No microbiology information is required to meet this entry criterion.

    • Pancreatitis. Pancreatitis of any aetiology.

Outbreaks or exposures of public health interest.

Patients from the groups specified below may be recruited even if they are not admitted to critical care.

Potentially life-threatening complications of vaccines.

Note that since these complications are all potentially life-threatening, patients will be eligible even if they are not admitted to a continuous monitoring/critical care area. This will include confirmed or suspected:

  • Cerebral venous sinus thrombosis,
  • Deep vein thrombosis/pulmonary embolism,
  • Other thrombotic events, with or without thrombocytopaenia,
  • Neuroinflammatory disorders including Guillain-Barre syndrome,
  • Deep vein thrombosis/pulmonary embolism,
  • Anaphylaxis,
  • Vasculitis,
  • Other potentially life-threatening suspected complications of vaccine,

Unexplained hepatitis in children.

Patients under the age of 16 with elevated liver transaminase (ALT > 500 iU/L or AST > 500 iU/L), not due to other diagnoses such as hepatitis viruses A-E, autoimmune hepatitis, or poisoning.

Emerging Infections

Emerging infections are by their nature unpredictable and present a significant challenge to the international research community. In order to ensure research preparedness, in accordance with the principles laid out by the International Severe Acute and Emerging Infection Consortium (ISARIC)(Dunning et al. 2014), patients will be recruited to this study if they have confirmed or suspected infection with a novel pathogen, a new strain of an existing pathogen, or a re-emerging known pathogen, that causes life-threatening illness. This will include the Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS), highly pathogenic strains of influenza, Ebola virus disease and other epidemics of viral haemorrhagic fever.

Exclusion criteria

There are no exclusions to recruitment and no age restrictions. All consenting patients meeting the inclusion criteria will be included.

Additional groups

The following additional groups of people will be eligible for recruitment:

  • Patients recruited into participating ethically-approved clinical studies (listed here: https://genomicc.org/uk/trials) will be recruited to GenOMICC. This route of inclusion in GenOMICC will be available to research studies of conditions related to the above inclusion criteria, including, but not limited to, the ACCORD-2 and RECOVERY-PK studies of therapy for COVID-19.

  • Control groups. Although some comparison groups can be obtained from population genetic studies and from within the critically-ill population, additional controls may increase discovery power in this study for variants determining susceptibility to severe disease. Volunteers from the general population will be eligible to act as controls if they have no prior history of critical illness.