To study the genetic mechanisms that control the processes leading to life-threatening illness
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: R652- Severe sepsis
- Registration Number
- CTRI/2022/01/039591
- Lead Sponsor
- Asian Healthcare Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 â?? >â??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:
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.
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 Syndro
Exclusion criteria do not apply to COVID-19. All consenting COVID-19 patients will be included. For all inclusion categories apart from COVID-19, patients who are functionally limited by any comorbid illness (such as frailty, heart failure, chronic obstructive pulmonary disease (COPD), or reduced exercise tolerance of any cause) or have significant immunosuppression (such as cancer chemotherapy or acquired immune deficiency syndrome) will be excluded from this study.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MortalityTimepoint: The outcome of mortality will be measured at 60 days from the first time the patient met the medical criteria for inclusion in the study.
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable