Evaluation of interventions linked to treatable traits in acute critical illness in adults to enable precision medicine: Data enabled Bayesian adaptive platform randomised clinical trial with embedded biological characterisation (TRAITS Trial)

niversity of Edinburgh0 个研究点目标入组 2,000 人开始时间: 2023年9月20日最近更新: 2023年11月20日

适应症

试验速览

阶段: 4 期
状态: 进行中（未招募）
发起方
入组人数: 2,000

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•Platform inclusion
•1. Aged =18 years
•2. Provision of consent (including deferred consent in accordance with Section 5.2)
•3. Receiving organ support in a critical care setting
•4. Organ dysfunction of at least one organ (SOFA Score>=2)
•5. In clinical team’s opinion is likely to require organ support* for =24 h post randomisation
•6. Resident in Scotland (required for ongoing data linkage)
•*Organ support is defined as treatments provided in the critical care units to support one or more of the organ systems, as per the critical care minimum dataset (please see link: https://www.datadictionary.nhs.uk/attributes/organ_system_supported.html). Respiratory support refers to provision of invasive or non-invasive mechanical ventilation, including high-flow nasal cannula with a flow rate =30 L per minute and fractional inspired oxygen concentration =30%). Cardiovascular support refers to infusion of vasopressor or inotropes. Renal support refers to provision of renal replacement therapy.
•Appendix 1: LYMP-RESP TSP inclusion
•1. Provision of consent
•2. Respiratory dysfunction is defined as PaO2/FiO2 ratio <40 KPa whilst receiving respiratory support with either non-invasive ventilation (including high flow nasal cannula) or invasive mechanical ventilation for 6 hours or longer. Arterial blood gas samples taken within 3 hours of trait eligibility assessment can be used to determine the PaO2/FiO2 criteria.
•3. Lymphopenia defined as lymphocyte count <1.2 x 10(9)/L. The lymphocyte count measurements from blood samples done as part of routine clinical care, +/- 36 h of critical care admission could be used. The time window of +/- 36 h reflects the current routine clinical ordering of full blood counts.
•Appendix 2: ENDO-SHOCK TSP inclusion
•1. Provision of consent
•2. Presence of shock: defined as hypotension requiring vasopressor therapy to maintain mean blood pressure 65 mm Hg or greater (equates to cardiovascular SOFA score of 2 or more) and having a blood lactate level greater than 2 mmol/L after adequate initial fluid resuscitation. The term adequate is a clinical judgement. The term initial fluid resuscitation refers to the first set of fluid administration in patients presenting with shock, and acknowledges the fact that resuscitation is an ongoing process. The lactate measurement done as part of routine clinical care using either arterial or venous blood gas, around the time of resuscitation could be used.
•3. Evidence of inflammation: defined as C-reactive protein (CRP) 50 mg/L or more OR neutrophil count >=12 x 10(9)/L. The CRP levels and neutrophil count measurements from blood samples done as part of routine clinical care, around the time of trait eligibility assessment (+/- 36 h window) could be used. The time window of +/- 36 h reflects the current routine clinical care.

排除标准

•Platform exclusion
•1. In the Investigator’s opinion, the participant is unwilling or unable to comply with the trial intervention and/or procedures
•2. Patients was admitted to ICU more than 48 h ago
•3. Primary neurological ICU diagnosis
•4. Neuromuscular disease and long-term home ventilation
•5. Organ transplantation within 90 days
•6. Patient not expected to survive 24 hours by the clinician responsible for clinical care
•7. Decision to provide only palliative or end-of-life care
•8. Prisoners
•9. Previous randomisation on the TRAITS trial
•10. Individuals with permanent incapacity
•11. Known or suspected pregnancy [Note: pregnancy test result is not required for women of childbearing potential (WOCBP) when assessing platform eligibility]
•12. Breast feeding
•Appendix 1: LYMP-RESP TSP exclusion
•1. Known hypersensitivity to study products or any of its excipients (excipients listed in section 6.1 of the representative SmPC)
•2. More than 48 h has elapsed since ICU admission.
•3. Patient is known to be pregnant. (A pregnancy test in females with childbearing potential (aged 15-55 years) will be performed prior to enrolment and patients who are pregnant will be excluded.
•4. Breastfeeding
•Intervention-specific exclusion criteria - Budesonide
•5. Patient is already receiving, or a clinical decision has been made to commence inhaled or intravenous corticosteroids
•Intervention-specific exclusion criteria – Baricitinib
•6. Patients with active TB
•7. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product. Diagnosis of sepsis is not a contraindication, given that COVID-19 patients will meet the sepsis case definition.
•8. Have received any live vaccine within 4 weeks before screening
•9. Alanine aminotransferase (ALT) or an aspartate aminotransferase (AST) > 5 times the upper limit of the normal range
•10. Estimated glomerular filtration rate (eGFR) of less than 30 mL/min per 1.73 m², immediate need for hemodialysis or hemofiltration;
•11. In the opinion of the investigator, unlikely to survive for at least 48 h after screening.
•12. Have neutropenia (absolute neutrophil count <1x10(9) cells/L)
•13. Have severe lymphopenia (absolute lymphocyte count <0.20x10(9) cells/L)
•Appendix 2: ENDO-SHOCK TSP exclusion
•1. Known hypersensitivity to imatinib or any of its excipients (excipients are listed in section 6.1 of the representative Summary Product of Characteristics (SmPC),
•2. More than 48 h has elapsed since ICU admission.
•3. Patient is known to be pregnant. (A pregnancy test in females with childbearing potential (aged 15-55 years) will be performed prior to enrolment and patients who are pregnant will be excluded.
•4. Breastfeeding
•Intervention-specific exclusion criteria – Imatinib
•5. Patient is already receiving,

研究者

发起方

niversity of Edinburgh

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