Co-enrol
Studies eligible for co-enrolment with FLO-ELA:
A-STOP Trial
A multi-centre, prospective, diagnostic test accuracy study to assess the performance of three commercially available rapid tests for Candida infection (beta-D-glucan and two PCR-based tests) in the UK critical care setting.
ISRCTN: 43895480ADAPT-Sepsis Trial
A randomised controlled, single-blinded, multi-centre trial aiming to determine whether treatment protocols based on monitoring daily CRP (C-reactive protein) or PCT (procalcitonin) safely allow a reduction in duration of antibiotic therapy in hospitalised adult patients with suspected sepsis.
ISRCTN: 47473244Add-Aspirin Trial
A phase III, double-blind, placebo-controlled, randomised trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common non-metastatic solid tumour.
ISRCTN: 74358648A2B Trial
A randomised, parallel-group, allocation concealed, controlled, phase 3 trial to determine whether the alpha-2 agonists, clonidine or dexmedetomidine (or both) are clinically cost effective in mechanically ventilated ICU patients compared to current usual care.
ClinicalTrials.gov Identifier: NCT03653832CAMELOT
Continuous rectus sheath Analgesia in eMErgency LaparOTomy. A Multi-centre, randomised sham-controlled trial of rectus sheath catheter-delivered local anaesthetic infusion compared with usual care in patients undergoing emergency bowel surgery.
The trial aims to find out whether adding Rectus Sheath Catheters (RSCs) to standard morphine patient-controlled analgesia (PCA) provides better pain relief, fewer side effects and complications, and greater satisfaction for patients undergoing emergency laparotomy. It will also determine whether they are safe and cost-effective.
ISRCTN: 15475290CReST2
A blinded, multi-centre randomised controlled trial to compare the effect of uncovered and covered stents on the quality of life of people with inoperable obstructing colorectal cancer who are managed by undertaking an urgent decompression and stenting.
ISRCTN: 54834267ELF2-Defining the Denominator
A multicentre prospective cohort study that aims to identify a U.K. consecutive series of older adults presenting with acute abdominal pathology potentially treatable by emergency laparotomy where the decision is made not to undergo surgery (NoLAP) and their associated 90-day mortality. To collect, define and characterise the reasoning behind the NOLAP decision and define potential prognostic markers for mortality that could aid decision-making in the future (including frailty, NELA score and sarcopenia).To compare to those that underwent surgery (ELAP) during the same time frame as the NoLAP population.
GuARDS
Glucocorticoids in adults with acute respiratory distress syndrome: A randomised, parallel-group, allocation-concealed, open-label, pragmatic, group-sequential design, clinical and cost-effectiveness trial with internal pilot. The aim of the study is to answer if dexamethasone treatment in patients with ARDS can save lives, reduce the need for extended ICU care, improve longer term patient quality of life and find the best value for the public and health services.
HMB-ICU
A double blind, placebo controlled, randomised controlled trial to investigate the effect of β-Hydroxy-β-Methylbutyrate (HMB) on skeletal muscle wasting in early critical illness.
ClinicalTrials.gov Identifier: NCT03464708iRehab
A randomised controlled trial with an embedded process evaluation to investigate, in survivors of critical illness following discharge from an Intensive Care Unit (ICU) admission, the effects of a six-week remote multicomponent rehabilitation intervention compared to standard care on health-related quality of life at eight weeks post-randomisation.
ISRCTN: 11266403MARCH Trial
To determine whether the use of two mucoactives (carbocisteine or hypertonic saline), or a combination of both, during mechanical ventilation in critically ill patients with acute respiratory failure improves outcomes and is cost effective, compared to usual airway clearance management.
ISRCTN: 17683568MOSAICC
This is a randomised trial to evaluate whether treatment with intravenous (IV) sodium bicarbonate compared with standard treatment in critically ill adults with metabolic acidosis and acute kidney injury (AKI), improves mortality at 90 days post randomisation (clinical effectiveness), incremental costs, quality-adjusted life years (QALYs), and net monetary benefit (cost effectiveness) at 90 days.
ISRCTN: 14027629PEPTIC
A large, multi-centre, cluster cross over, randomised registry trial comparing the safety and efficacy of proton pump inhibitors with histamine-2 receptor blockers for ulcer prophylaxis in intensive care patients.
PQIP
Improving perioperative care through the use of quality data: Patient Study of the Perioperative Quality Improvement Programme.
PREVENTT Trial
A randomised double-blind controlled phase III study to compare the efficacy and safety of intravenous ferric carboxymaltose with placebo in patients with anaemia undergoing major open abdominal surgery.
ISRCTN: 67322816PRISM Trial
An international, multi-centre, pragmatic, randomised controlled trial with open study group allocation, to determine if routine continuous positive airway pressure (CPAP) for four hours immediately after major abdominal surgery is effective prophylaxis against postoperative pneumonia, re-intubation or death.
ISRCTN: 56012545REST Trial
A pragmatic randomised controlled trial to determine whether Extracorporeal Carbon Dioxide Removal (VV-ECCO2R) and lower tidal volume mechanical ventilation in patients with hypoxaemic respiratory failure improves 90 day mortality.
ClinicalTrials.gov Identifier: NCT02654327ROSSINI 2
A multi-arm, multi-stage (MAMS) pragmatic, multicentre, randomised controlled trial, with an internal pilot determining whether three specific in-theatre interventions, alone or in combination, result in decreased rates of surgical site infection (SSI) up to 30 days post operation in adult patients undergoing abdominal surgery.
ISRCTN: 78305317REALIST
This is an open label dose escalation phase 1 trial followed by a randomised, double-blind, placebo-controlled phase 2 trial.
Clinical Trials.gov IdentifierNCT03042143SINFONIA
SINFONIA is a pragmatic multi-centre randomised trial in patients aged at least 50 years who are undergoing major thoracic or abdominal surgery, and will generate robust data on the risks and benefits of the two alternative drugs. Patients will be randomly assigned to sugammadex or neostigmine and followed up to detect patient-centred outcomes.
ISRCTN:15109717STRESS-L Trial
A randomised trial to assess whether the addition of a beta blocker infusion (landiolol) to standard treatment in patients with septic shock, requiring prolonged (>24 hours) support with high-dose vasopressor agents, improves organ failure.
ISRCTN: 12600919SUNRISE
Single Use Negative pRessure dressing for Reduction In Surgical site infection following Emergency laparotomy. An RCT to determine if the use of a SUNPD in adult patients undergoing emergency laparotomy reduces surgical site infection (SSI) at 30 days compared to surgeon’s preference of dressing.
ISRCTN: 17599457T4P Trial
This is a prospective randomised, comparative effectiveness trial to define the platelet count below which critically ill patients should receive a platelet transfusion prior to an invasive procedure.
ISRCTN: 79371664VACIRISS Trial
Pneumococcal Vaccination to accelerate Immune Recovery in Sepsis Survivors: randomized placebo-controlled trial.
ClinicalTrials.gov Identifier: NCT03565159
Studies NOT eligible for co-enrolment with FLO-ELA:
OPTIMISE II Trial
An international, multi-centre, pragmatic, randomised controlled trial with an open study group allocation, to determine whether cardiac output-guided fluid therapy, with a low dose inotrope infusion is clinically effective when compared to usual care in patients undergoing major gastrointestinal surgery.
ISRCTN: 3965375665 Trial
Evaluating the clinical and cost effectiveness of using a more conservative mean arterial pressure target range to guide careful titration of vasopressors to minimise dose and duration in older critically ill patients with vasodilatory hypotension: the 65 trial.
ISRCTN: 10580502LaCeS2 Trial
LaCeS2 is a phase III, multicentre, randomised controlled superiority trial investigating the effectiveness and cost-effectiveness of keyhole (laparoscopic) colorectal emergency surgery compared to open surgery, and follows on from the LaCeS Feasibility Trial.
ISRCTN: 38815804UK-ROX Trial
Evaluating the clinical and cost-effectiveness of a conservative approach to oxygen therapy for invasively ventilated adults in intensive care. In non-elective adults receiving mechanical ventilation and supplemental oxygen in the intensive care unit, conservative oxygen therapy is superior to usual oxygen therapy, in terms of all-cause mortality at 90 days.
ISRCTN: 13384956
