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This study aims to identify genetic predisposition to specific syndromes of critical illness. Specifically, susceptibility to life-threatening infections caused by an identified pathogen, and susceptibility to death following the onset of organ failure due to sepsis or sterile injury.

INCLUSION CRITERIA

The INCLUSION criteria were updated to include all patients receiving  organ support and who have sepsis of any type. Organ support includes high flow, pressors/inotropes, renal replacement.

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Patients can be included IF they

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  • 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:

  • 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 public website at https://genomicc.org/investigators/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

EXCLUSION CRITERIA

·         Bone marrow transplant recipients



 

Study Information

Confirming eligibility - after initial screening, if eligible, complete and sign the Randomisation Form. 

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Consent- Due to the time critical nature of the study and virtue of inclusion criteria, this study has been given an 'emergency waiver of consent' . This means that patients may be enrolled prior to obtaining consent. However, this may only be done in case of incapacitated patients. Once the 'emergency period' is over, approximately 24-48 hrs later (or sooner, if possible), consent must be sought. 

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Patient Consent - 1st line

Personal Consultee - 2nd line

Nominated Consultee - 3rd line

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© 2035 by Dr Phil Hopkins

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