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

Recruitment poster

We have a poster that can be displayed in staff areas summarising patient eligibility - Staff poster

We would be very happy to localise, laminate and send some copies to you. Just Let us know.

Entry criteria

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

23 October 2024 v5.0

Patients will be recruited who:

• Are deemed, in the view of the treating clinician, to require continuous cardiovascular or respiratory monitoring or any organ support
• AND provide appropriate consent or assent
• AND whose primary reason for admission is one of the following primary diagnoses:

Critical illness caused by any confirmed or suspected infection

OR

Common non-infectious critical illness syndromes:

• Pancreatitis of any aetiology
• Full thickness burns covering >20% of body surface area

Rare non-infectious critical illness syndromes:

• Haemophagocytic syndrome
• Still’s disease
• Heat stroke
• Radiation poisoning
• Suspected reactions to therapeutic agents:
  • This includes cell therapies, gene therapy, CAR T-cell therapy, investigational drugs or vaccines in the view of the treating clinician. For example:
    • Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), or SJS-TEN overlap to any therapeutic agent
    • Cell therapy associated reaction
    • Acute hepatitis associated with gene therapy in any age group

Confirmed or suspected presence of an emerging critical illness syndrome, such as:

• unexplained or idiosyncratic presentations of acute organ injury in the view of the treating clinician
• confirmed or suspected exposures of public health interest in the view of the study leadership in consultation with public health agencies. An updated description of these syndromes will be maintained by the central study team on the our website: Emerging syndromes

Non-infectious critical illness syndromes in children or babies:

• Preterm birth (babies born <32 weeks postmenstrual age)
• Acute seronegative or 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

Organ Support

Examples of eligible organ support include, but are not limited to:

• Respiratory: High flow nasal oxygen (HFNO), Continuous positive airway pressure (CPAP), Non-invasive ventilation (NIV), Invasive mechanical ventilation (including following intubation for airway protection)
• Cardiovascular: any vasopressors or inotropes that are given by continuous infusion, extracorporeal membrane oxygenation (ECMO)
• Renal: continuous or intermittent haemofiltration/dialysis/diafiltration where it is used to treat acute disease in a patient who is not normally in receipt of renal support

Exclusion Criteria

The following participants are not eligible for participation in any part of the GenOMICC study:

• Bone marrow transplant recipients