Trials
The Best Critical Care Trials in the World
These are the first presentations of the results of major critical care trials and usually occur in conjunction with a simultaneous publication in a major general medical journal. Each results session lasts 60 to 90 minutes, including time for the results presentation, independent editorial, questions and a panel discussion.
Results Presentations
The Best Critical Care Trials in the World
VICTORY
The VICTORY trial is a multicentre, double-blind, randomised controlled study evaluating high-dose intravenous vitamin C in patients with severe, life-threatening burn injury. Adults aged 18 years or older with deep second- and/or third-degree burns involving at least 20% total body surface area and requiring skin grafting are enrolled across more than 40 burn centres worldwide. Participants are randomly allocated to receive intravenous vitamin C at a dose of 200 mg/kg/day for 96 hours or matched placebo, in addition to standard burn care. The trial is grounded in the hypothesis that profound inflammation, oxidative stress, and metabolic derangement following severe burns may be mitigated by high-dose vitamin C, leading to less organ dysfunction and improved recovery. The primary outcome is time to discharge alive from hospital, with secondary outcomes including hospital and ICU length of stay, need for organ support, hospital and 6-month mortality, health-related quality of life, and healthcare resource use. If successful, this inexpensive and widely available intervention could have global impact on outcomes after severe burn injury.
FISSH
Trial Registration | Trial Protocol
The Fluids in Septic Shock (FISSH) trial examines whether chloride load influences outcomes in patients with early septic shock requiring substantial intravenous fluid resuscitation. This international, multicentre, randomised controlled trial compares strategies based on high-chloride fluids (0.9% saline or high-chloride albumin) versus low-chloride fluids (Ringer’s lactate or low-chloride albumin). By allowing albumin with differing chloride concentrations alongside crystalloid assignment, the trial isolates cumulative chloride exposure rather than fluid class alone. FISSH builds directly on an earlier pilot phase study and targets a high-risk septic shock population most likely to demonstrate clinically meaningful effects. The primary outcome is 30-day mortality, with key secondary outcomes including acute kidney injury and ICU length of stay. With over 1,000 patients enrolled across multiple international centres, FISSH has the potential to guide fluid resuscitation practice for critically ill patients with infection worldwide.
GASTRIC-PICU
Trial Registration | Trial Protocol | Website
GASTRIC-PICU is a large UK multicentre, randomised, open-label, non-inferiority trial evaluating whether routine gastric residual volume (GRV) measurement is necessary to guide enteral feeding in mechanically ventilated children in paediatric intensive care. Enrolling 4,700 patients across 19 UK PICUs, it compares no routine GRV measurement, using clinical signs of feed intolerance, with standard care involving at least 6-hourly GRV monitoring. The co-primary outcomes assess non-inferiority for survival and ventilator-free days at 30 days and superiority for achievement of energy targets at 72 hours. Secondary outcomes include ventilator-associated pneumonia, necrotising enterocolitis, feeding interruptions, length of stay, mortality, health-related quality of life, and costs, alongside a health-economic evaluation. The findings will determine whether routine GRV monitoring can be safely abandoned without harm while improving nutritional delivery and resource use in PICU practice.
BIHCA
Trial Registration | Trial Protocol | Website
The BIHCA trial is a multicentre, randomised, double-blind, placebo-controlled superiority trial evaluating sodium bicarbonate during adult in-hospital cardiac arrest. Conducted across 21 Danish hospitals, it plans to enroll 778 adults who receive at least one dose of adrenaline and randomizes them 1:1 to receive up to two boluses of 50 mmol sodium bicarbonate or matching placebo. The intervention is administered immediately after the first adrenaline dose, with a second dose after the second adrenaline dose if arrest persists. The primary outcome is sustained return of spontaneous circulation, defined as circulation without chest compressions for at least 20 minutes. Key secondary outcomes include 30-day survival and 30-day survival with a favourable neurological outcome (modified Rankin Scale 0–3). The trial is powered to detect an absolute 10% increase in return of spontaneous circulation and uses site-stratified randomisation with full blinding. BIHCA aims to provide definitive contemporary evidence on the role of bicarbonate in in-hospital cardiac arrest care.
ARISE FLUIDS
Trial Registration | Trial Protocol | Website
ARISE FLUIDS is a large, pragmatic, multicentre randomised controlled trial enrolling adults with early septic shock presenting to emergency departments in Australia, New Zealand, and Ireland. It compares a restrictive intravenous fluid strategy with early vasopressor initiation against a more fluid-led approach during the first 6–24 hours of haemodynamic resuscitation. Randomisation occurs early, within hours of presentation, directly targeting front-line sepsis management. The trial prioritises patient-centred outcomes, with days alive and out of hospital at 90 days as the primary endpoint, alongside mortality, organ support–free days, and longer-term disability. ARISE FLUIDS directly tests a foundational assumption of international sepsis guidelines and addresses one of the most consequential decisions clinicians make in septic shock.
LOGICAL
Trial Registration | Trial Protocol
LOGICAL is a large, international, multicentre randomised controlled trial enrolling comatose adults in the ICU with suspected hypoxic–ischaemic encephalopathy following cardiac arrest. It compares a conservative oxygen strategy with a liberal oxygen strategy during invasive mechanical ventilation, aiming to limit hyperoxia while avoiding clinically significant hypoxaemia. The trial recruits 1,400 patients across ICUs in Australia, New Zealand, and Ireland and is embedded within the broader Mega-ROX research programme. Randomisation occurs early after ICU admission, and the intervention is applied throughout the ICU stay. The primary outcome is survival with a favourable neurological outcome at 180 days, assessed using the Extended Glasgow Outcome Scale. Secondary outcomes include mortality, length of stay, discharge destination, quality of life, and cognitive function. LOGICAL directly addresses the long-standing uncertainty around optimal oxygen targets after cardiac arrest and focuses on neurological recovery rather than short-term survival alone