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Ongoing ICU Clinical Trials

Five active studies underway in our intensive care unit, spanning severe pneumonia, ARDS, sepsis and shock, genetic susceptibility to critical illness, and the safety of emergency airway procedures. All participation is voluntary and alongside standard medical care.

  1. ESSCAPE- A randomized, placebo-controlled, double-blind, multi-center, phase III trial to assess the efficacy and safety of trimodulin (BT588) in adult hospitalized subjects with severe community-acquired pneumonia (sCAP)

    Status: Recruiting
    Sponsor: Biotest AG

    Aim: Testing whether trimodulin, added to standard hospital care, improves recovery and survival in patients with severe pneumonia who require a ventilator.

    About severe pneumonia: a lung infection serious enough to stop the lungs working properly on their own, causing respiratory failure and the need for a ventilator to breathe.

    Design:
    Randomized, double-blind, placebo-controlled
    Treatment: Daily infusion for 5 days, followed 90 days
    Primary measure: Survival at 28 days
    Eligibility: age18 and older
    Full eligibility

    Who can take part

    • Age 18 or older, hospitalized with community-acquired pneumonia
    • Severe enough to require a ventilator, treatment started within 24 hours of ventilation
    • Blood test shows significant inflammation (CRP ≥ 70 mg/L)

    Who is not eligible

    • Pregnant or breastfeeding
    • Already on ECMO life support, or pneumonia acquired in hospital rather than the community
    • Significant pre-existing kidney, liver, lung or heart disease
    • Known allergy to human plasma proteins
    • Life expectancy under 90 days from an unrelated illness

    Suitability is confirmed by the study team on a case-by-case basis. Consent is obtained from the patient or their legally authorized representative before enrollment.

    Website link: Biotest-Esscape Trial

  2. GenOMICC - Genetics of Mortality in Critical Care 

    Status: Recruiting

    Sponsor: University College Dublin

    Aim: A blood sample and linked medical data help researchers understand why some people become critically ill from infections or injuries while others recover easily — part of a wider international collaboration.

    About critical illness: the point where organs such as the lungs, kidneys or heart begin to fail as the body responds to a severe infection or injury, sometimes called multi-organ dysfunction.

    Design: Observational, genetic (single DNA sample)
    Population: Adults and children, no upper age limit
    Consent: Patient, or family/representative if too unwell
    Target enrollment: ~500 in Ireland, 100,000 worldwide
    Full eligibility

    Who can take part

    • Critically ill patients from severe infection or major injury, including COVID-19, flu, RSV, pneumonia, sepsis, severe burns and pancreatitis
    • Patients on advanced life support such as ECMO
    • Volunteers exposed to infection with mild or no symptoms, as a comparison group

    Who is not eligible

    There are no exclusion criteria and no age limit — anyone meeting the illness criteria above can be considered.

    A single blood sample is taken alongside routine clinical bloodwork. Genetic results are not fed back to individual participants.

  3. PEGASUS- Personalized Mechanical Ventilation Guided by UltraSound in Patients with Acute Respiratory Distress Syndrome

    Status: Recruiting

    Sponsor: Amsterdam UMC

    Aim: Bedside lung ultrasound identifies how each patient's lungs are affected, letting doctors tailor ventilator settings instead of using one approach for every patient.

    About ARDS: Acute Respiratory Distress Syndrome — the lungs become inflamed and stiff, making it very hard to get enough oxygen into the blood, and usually requiring a ventilator.

    Method: Bedside lung ultrasound
    Condition: Moderate–severe ARDS (Berlin criteria)
    Primary measure: Survival at 90 days
    Trial size: 538 patients, ~40 ICUs worldwide
    Full eligibility

    Who can take part

    • Admitted to a participating ICU and invasively ventilated
    • Meets the standard clinical definition (Berlin criteria) for moderate or severe ARDS

    Who is not eligible

    • Under 18, or already on ECMO life support
    • Lung ultrasound isn't practical (e.g. severe obesity, wounds or surgical dressings on the chest)
    • Chronic lung disease needing long-term home oxygen, or raised pressure in the brain
    • Considered too unwell to benefit, or nearing end of life.

    Website link: PEGASUS Trial

  4. PREVENTION- Preventing caRdiovascular collapsE with VasoprEssors duriNg Tracheal IntubatiON

    Status: Recruiting

    Sponsor: Università degli Studi di Torino

    Aim: Emergency intubation can cause a dangerous drop in blood pressure. This trial tests whether starting noradrenaline before the procedure prevents severe hypotension and cardiac arrest.

    About the risk: intubation is the placement of a breathing tube; in patients who are already critically ill, the medications and pressure used can suddenly drop blood pressure or trigger cardiac arrest.

    Design: Randomized: early noradrenaline vs. standard care
    Primary measure: Low blood pressure or cardiac arrest within 30 min
    Excludes: Planned, non-emergency intubations
    Eligibility age: 18 and older
    Full eligibility

    Who can take part

    • Adult ICU or hospital patients requiring emergency intubation
    • At risk of low blood pressure during the procedure
    • Enrollment depends on the clinical team's judgment in the moment

    Who is not eligible

    • Already on blood pressure-supporting medication, or blood pressure already very high or low
    • Intubation happening during CPR for cardiac arrest
    • Known allergy to noradrenaline, or known/suspected pregnancy

    Because intubation is a life-saving emergency, patients are enrolled without prior consent; the patient or family is fully informed afterward, once the person has recovered enough to understand.

  5. REACT-SHOCK- Individualised Blood Pressure Targets versus Standard Care among Critically Ill Patients with Shock: A Multicentre Randomised Controlled Trial 

    Status: Recruiting

    Funded by: Australia's Medical Research Future Fund

    Aim: Rather than one fixed target for every patient, this international trial sets blood pressure goals based on each patient's own pre-illness baseline, aiming to improve survival and reduce complications like kidney injury.

    About shock: blood pressure drops so low that organs like the kidneys and brain stop getting enough blood flow, requiring medications called vasopressors to bring it back up.

    Design: International RCT
    Comparator: Personalized vs. fixed BP target
    Primary measure: Survival at 14 days
    Trial size: 1,260 patients, 25+ ICUs worldwide
    Full eligibility

    Who can take part

    • Adults aged 40 or over, in ICU with shock and dangerously low blood pressure
    • Requiring vasopressor medication to maintain blood pressure
    • Shock from any cause — severe infection, heart problems or other serious illness
    • At least two blood pressure readings from before the illness are available, to set a personal baseline

    Who is not eligible

    • Trauma as the main reason for ICU admission, known or suspected pregnancy
    • Kidney failure needing dialysis, or already on ECMO or a heart pump
    • A brain, spine or aortic condition needing its own specific blood pressure target
    • Considered too unwell to benefit from further treatment
All trials are conducted alongside, not instead of, standard intensive care, and each has been approved by the relevant hospital research ethics committee. Participation is voluntary, and eligibility is confirmed by the clinical research team before enrollment. 

 

Contact Us

Have a question about ICU research trials? Get in touch with the Critical Care Research Team.

Phone: 091 898 375

Email:
liestamarie.lisaba@universityofgalway.ie
celia.thomas@universityofgalway.ie