Recently Completed CTN Endorsed Trials

PHARLAP

PHARLAP

The PHARLAP-RCT was a prospective, multi-centre, randomised controlled trial of the clinical efficacy of a ventilation strategy (called PHARLAP) compared to standard mechanical ventilation in acute respiratory distress syndrome (ARDS). This trial was a collaboration between Intensive Care Units of the Irish Critical Care- Clinical Trails Group (ICC- CTG) and the Australian and New Zealand Intensive Care Society- Clinical Trials Group (ANZICS-CTG).

The PHARLAP open lung ventilation strategy consists of Permissive Hypercapnia, Alveolar Recruitment and Low Airway Pressures. Recruitment was suspended early with 115 patients enrolled and the data has been analysed. The results of this study were presented at the Critical Care Reviews Meeting 2019 and will be published soon.

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PEPTIC

PEPTIC

PEPTIC is a multi-centre, cluster crossover, randomised trial comparing proton pump inhibitors (PPIs) with histamine-2 receptor blockers (H2RBs) for ulcer prophylaxis in mechanically ventilated ICU patients. The overall objective of this study is to establish the risk of in-hospital death using PPIs vs. H2RBs for routine ulcer prophylaxis in mechanically ventilated patients in the ICU. Recruitment is completed and data analysis is ongoing, with results expected this year


TRANSFUSE

TRANSFUSE

TRANSFUSE-RCT is a multi-centre, randomised, controlled trial, testing the effect of the freshest available red blood cell (RBC) unit compared to standard practice, on mortality in critically ill patients who require RBC transfusion.

The results have recently been presented at ESICM2017 in Vienna and published in the New England Journal of Medicine.

TRANSFUSE's major finding was no difference in 90-day mortality between transfusion of freshest available RBCs or standard issue RBCs. This result supports the safety of current practice.

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SPICE III

SPICE III

SPICE III is a prospective, un-blinded, randomised controlled trial of Early Goal-Directed Sedation (EGDS) compared with standard care. The study recruited patients who are intubated and ventilated in a participating ICU, are expected to remain intubated the day after enrolment and need immediate and ongoing sedation. Recruitment is completed, data analysis is ongoing, and results are due shortly.

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EPIC III

EPIC III

EPIC III (a 24-hour point-prevalence study) was performed on September 13, 2017, World Sepsis Day. Data was collected on: demographics, infection management, degree of organ dysfunction and patient outcomes. EPIC III is supported by the World Federation of Societies of Intensive and Critical Care Medicine.

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WEAN SAFE

WEAN SAFE

WEAN SAFE (WorldwidE AssessmeNt of Separation of pAtients From ventilatory assistancE) is a multi-centre, prospective, observational, 4-week inception cohort study being carried out by the Acute Respiratory Failure section of ESICM. Weaning represents a challenge for intensivists and patients spend a considerable amount of time in being liberated from mechanical ventilation. While guidelines do exist on the classification of weaning, a recent study has shown that these may not be applicable to all patients. Moreover, different practices exist in regard to weaning procedures. WEAN SAFE will prospectively assess the burden of, management and spectrum of approaches to weaning from ventilation, in patients that require invasive mechanical ventilation for any reason, for a time period of at least 24 hours.

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POSE

POSE

POSE (Peri-interventional Outcome Study in the Elderly) is an an investigator initiated European, multi-centre, observational cohort study. It will predict critical stages and outcomes in a large sample of all surgical and non-surgical interventional patients ≥80 years of age in Europe.

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STOP-AKI

STOP-AKI

A randomized, double-blind, placebo-controlled, four-arm, parallel-group, proof of concept, and dose-finding adaptive phase 2a/2b study to investigate the safety, tolerability and efficacy and effect on quality of life of human recombinant alkaline phosphatase in the treatment of patients with sepsis-associated acute kidney injury.

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