• Prospective multicenter Observational study on Transfusion practice in vv-ECMO Patients: The PROTECMO Study
What and Why?
The PROTECMO study will provide new insights on the topic of transfusion management of critically ill patients undergoing VV-ECMO.
The optimal management of anticoagulation targets and transfusion practice in veno-venous-ECMO (VV-ECMO) patients is still under debate. Traditionally, the threshold for transfusions of packed red blood cells (PRBC) in ECMO is aimed at keeping hemoglobin (Hb) values in the normal range (12-14 g/dL), but some case series have shown how the Hb target can be lower, and with comparable clinical outcomes.
Recently, in the EOLIA trial, which enrolled patients from 2011 to 2017, the Hb level was set per protocol between 8 and 10 g/dl (with a planned possible increase in the case of persistent hypoxemia), far from the level recommended in the CESAR trial (protocolized between 12 and 14 g/dl), which included patients ten years before.
PROTECMO will highlight what blood products out ECMO patients receive, how and when they are administered in the current evolving equipment scenario for ECMO.
The principal aim is to describe current effective blood product usage, during VV-ECMO. The secondary aim is to describe in a large cohort of ECMO patients the current anticoagulation strategy and bleeding episodes occurrence.
The study is designed as a prospective observational multicenter cohort study.
No intervention. No additional tests. All data to be collected from the patient’s file and just data adopted in the current practice of each ECMO center will be recorded.
The data collection will include pre-ECMO characteristics, transfusion strategies and blood test results during the first twenty-eight days after ECMO cannulation or until the end of ECMO support if the length is shorter, and clinical outcomes up to the end of ICU stay.
Inclusion criteria/patient selection
All patients who receive extracorporeal lung support (ECMO) for ARDS respiratory causes will be included. Of note, considering the observational design of our study, patients can be included in other studies concurrently (this will be noted on the CRF).
Exclusion criteria: refusal to include
Jehovah’s witnesses and all patients refusing transfusions for personal reasons will not be excluded, but they will be analyzed separately.
Duration of the study
12 consecutive months or 20 consecutive VV-ECMO runs per intensive care unit, whichever comes first.
A flexible start of the inclusion period will be allowed for each ICU to facilitate participation in the study. Enrollment of ICU will last until the end of March 2019.
Do I need IRB approval?
Ethical requirements for data collection vary within countries and jurisdictions. Where appropriate, ethical approval and requirement or waiver for consent of participation will be obtained for each country by the country coordinator and where required by the local primary investigator at each site.
The promoting center, IRCCS-ISMETT, based on the Italian Privacy code will ask to relatives and informed consent for the participation in the study and for data protection. The study coordinator may provide a template in English for these consents.
All data will be reported in a centralized online and Web-based fully encrypted database (REDCAP). The study coordinator will regularly contact the local PI to ensure data collection and reporting as well as completion of patient follow-up.
Is there any financial compensation?I
No. Participation in the trial is completely voluntary. In every center 2 investigators will be listed as collaborators; some of the national coordinators, according to the entity of data and type of journal will be listed as authors. The multifaceted aspect of this prospective study will allow probably the publication of more than one manuscript and will give the opportunity for a larger involvements of the investigators.
How do I participate?
We are calling for ICUs from all over the world and we are seeking national coordinators. Express your interest sending an email and you will be contacted for center recruitment form.
The project has not received any external financial support and is currently supported by IRCCS-ISMETT.
- Antonio Arcadipane, Gennaro Martucci (IRCCS-ISMETT, Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione, Palermo – Italy)
- Antonio Pesenti, Giacomo Grasselli (University of Milan)
- Daniel Brodie (Columbia University, New York)
- Hergen Buscher (St. Vincent’s Hospital, Sydney, Australia)
- Giuseppe Foti (University of Monza)
- Marco Ranieri (University of Rome)
- Peter Schellongowski (University of Vienna)
- Matthieu Schmidt (University of Paris)
- Kenichi Tanaka (University of Maryland)
National Coordinators (Ongoing selection)
- Italy: G. Panarello, Palermo
- Spain and South America: J. Riera, Barcelona
- France: M. Schmidt, Paris
- Austria: P. Scellongowski, Vienna
- UK: A. Retter, London
- Australia, New Zeland, Asia: H. Buscher, Sydney
• SQUEEZE, a prospective multi-centre international observational study of postoperative vasopressor usage
Initiated in the ESICM POIC Section, this is a European Society of Anaesthesiology Clinical Trial Network (ESA CTN) sponsored study and it has been endorsed by ESICM.
Dr. Ib JAMMER (Haukeland University Hospital – Bergen, Norway)
Dr. Ben Creagh-Brown (Royal Surrey County Hospital NHS Foundation Trust – Guidlford, United Kingdom)
Download the study flyer here
In the era of goal-directed fluid therapy and increasing popularity of restrictive fluid resuscitation, patients may be receiving less intravenous fluid and receiving more infused vasopressors to maintain adequate blood pressure.
There is anecdotal evidence of substantial variation in the management of post-operative hypotension between centres, countries and continents. The variation is in assessment (cardiac output and invasive monitoring) and environment (post-operative care units, high-dependency units, ICUs) and management (use and choice of fluids and vasopressors/inotropes).
In critically ill populations, receipt of infused vasopressors is associated with organ dysfunction, it has not been established if this relationship is true in postoperative populations.
To evaluate the proportion of non-cardiac surgical patients receiving postoperative vasopressors.
To evaluate the characteristics of patients, surgery and anaesthesia that lead to postoperative vasopressor use.
To evaluate the incidence of organ injury in patients who receive postoperative vasopressors
To evaluate the variability in postoperative vasopressor use across healthcare environments.
Incidence of vasopressor use, and elucidation of risk factors
Postoperative organ dysfunction in patients receiving infused vasopressors.
Study selected by ESA Research Committee: April 2018
Call for centres: Ongoing
Finalizing protocol: Autumn 2018
Recruitment of patients: foreseen for Autumn 2019
How do I participate?
This study will recruit as many participating institutions as possible across the 30 European countries represented at the ESA Council. It is plan to recruit at least 40,000 patients.
Would your hospital like to join this study as an actively contributing research centre? The ‘Call for Centres form’ must be filled in online. The completion of this form will facilitate the coordination and is mandatory for participation in ESA CTN. The ESA Secretariat will contact you to provide you with additional information. Please visit the call for centres page.
Ib Jammer (Norway), Ben Creagh-Brown (UK), Lui Forni (UK), Ramani Moonesinghe (UK) and Hannah Wunsch (Canada).
National Coordinating Investigators: The ESA Secretariat and Steering Committee are looking for National Coordinating Investigators to support the conduction of SQUEEZE study, if you are interested, please contact it at SQUEEZE@esahq.org.
• INternational observational study To Understand the impact and BEst practices of airway management in critically ill patients (INTUBE)
INTUBE study is a large multi-centre, prospective, observational study on airway management in critically ill patients.
Endotracheal intubation (ETI) is a potentially life-threatening procedure for critically ill patients and major severe complications such as severe hypoxia, cardiovascular collapse and cardiac arrest are common. This project aims to prospectively collect data on the current impact of ETI-related adverse events and current airway management practice in critically ill patients.
We will prospectively collect data from 1000 ETI-related major complications from at least 180 centres worldwide. Each center will be asked to collect data from 20 ETIs.
All adult (≥ 18 year) critically ill patients undergoing in-hospital ETI. We will exclude patients undergoing ETI during cardiac arrest or anesthesia.
From 1 October each center will select a start date for recruitment and data collection of 20 ETIs (with a maximum time window of 8 weeks for each center).
How do I participate?
We are looking for either academic or non-academic centres caring critically ill patients around the globe. Please register your interest here
Contact: Vincenzo Russotto
• Extubation strategies in Neuro-ICU patients and associations with outcomes – ENIO
The ENIO study is an international observational study, about the practices of the mechanical ventilation weaning processes in patients hospitalised in the ICU with a severe brain-injury (trauma, haemorrhage, stroke…). The study will focus on extubation and/or tracheostomy. One of the primary target is to identify factors of extubation success in these patients and delineate the consequences on outcomes, which will be collected in the ICU and at hospital discharge.
The goal is to recruit at least 60 centres worldwide in order to include 1500 patients with extubation and/or tracheostomy. Each centre is expected to include at least 20 patients with extubation and/or tracheostomy over a 6-month period.
Contact: Raphael Cinotti
• EURopean study on Encephalitis in intensive Care – the EURECA Study
This is a prospective observational multicentre study in European ICUs. All patients admitted to the ICU for probable or confirmed AE (2013 IDSA criteria) will be included. The target is 1000 patients admitted to the ICU for AE (5 consecutive patients in each participating ICU, targeted number of ICUs in Europe: 200)
Acute encephalitis (AE) is a severe neurological disorder associated with significant morbidity and mortality. Approximately 60% of patients with AE require ICU admission because of coma, seizures or acute respiratory failure. Determinants of neurological prognosis of these patients are not known.
The main aims of the project are to describe the epidemiology and outcomes of patients admitted to the ICU with all-cause acute (meningo-) encephalitis in European countries. Specifically, we aim to identify early indicators of poor neurologic outcome in this population and to identify challenges in the management in the ICU, namely: temperature management, neuromonitoring, seizure management, specific therapy (antibiotic therapy, steroids, IVIg..)
For more information, download the protocol.
This project won the ESICM Established Investigator Award 2017.
Contact: Romain SONNEVILLE – Bichat Claude Bernard University Hospital
• VIP2 Very old Intensive Care Patient-study 2: Development and validation of a prognostic score
This study will seek to develop a prognostic score based on a large prospective multicentre study of the critically ill very old, defined as patients ≥ 80 years, emergency admitted to an ICU. We will gather age-specific information about the elderly patient: frailty, cognitive function, activity of daily life and co-morbidity, in addition to organ failure score. Outcomes will be registered as outcome at 30 days (alive or dead) and 6 months in a sub study. Also an inter-rater variability will be registered in a sub-study within the main study.
Recruitment: ICU recruitment took place from the fall of 2017 until fall of 2018 and is now closed.
More information at www.vip2study.com
Contact: Hans Flaatten
This project won the ESICM Clinical Research Award 2017
Follow up of VIP1 study:
• iCareWean “Weaning from mechanical ventilation: comparison of open-loop decision support system and routine care, in general medical ICU”
The BEACON care system is an open-loop decision support device that works alongside current ventilator systems in the intensive care unit. BEACON utilises physiological measurements, available at the bedside, and integrates them through a series of linked mathematical models. BEACON then uses these models to provide advice as to the ventilator setting that best optimises the patient’s individual physiological requirements.
- Single-blinded RCT
- ICU patients undergoing mechanical ventilation across both Chelsea & Westminster Hospital and West Middlesex Hospital.
- Recruiting 275 participants in total across the two sites.
- Ventilator management determined by the BEACON Caresystem versus standard ventilator management.
- The primary outcome: Time on mechanical ventilation.
See protocol flowchart.
More information about the study is available here.
REC reference: 17/LO/0887; IRAS Project ID: 226610; HRA: NIHRA under review; Clinicaltrials.gov Registered; ESICM endorsement
• PROTECTION: PRessuresuppOrTvEntilation + sigh in aCuTehypoxemIcrespiratOry failure patieNts
This study, initiated within the ESICM PLUG (Pleural Pressure) Working Group, is a randomised controlled (RCT) on the effects of short cyclic recruitment maneuver (Sigh) added to pressure support ventilation (PSV) that will be conducted in several ICUs in different countries.
More information about the primary/secondary endpoints and on the inclusion and exclusion criteria available in the protocol here.
How do I participate?
Interested sites can contact Tommaso Mauri
Study Start Date
Tommaso Mauri, University of Milan and Ospedale Maggiore Policlinico, Milan, Italy
Laurent Brochard, Medical and Surgical Intensive Care Unit, Saint Michael’s Hospital, Toronto, Canada
Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy
Tommaso Mauri, Laurent Brochard, Jean-Michel Constantin, Giuseppe Foti, Claude Guerin, Jordi Mancebo, Paolo Pelosi, Marco Ranieri, Antonio Pesenti.
Carla Fornari and Sara Conti, University of Milan-Bicocca, Monza, Italy
Contact: Tommaso Mauri
• STARRT-AKI: STandard versus Accelerated initiation of Renal Replacement Therapy in Acute Kidney Injury
To determine whether, in critically ill patients with severe acute kidney injury (AKI), a strategy of accelerated (early) initiation of renal replacement therapy (RRT), compared to a standard (delayed) strategy for initiation of RRT contributes to improved 90-day survival and recovery of kidney function.
Multi-national, multicentre, open-label, randomised, controlled trial. The trial is currently enrolling participants in 6 countries at 44 sites. The trial anticipates a total of 14 countries and approximately 100 sites.
2,866 critically ill patients with evidence of severe AKI who do not have an urgent indication for initiation of RRT at the time of screening but who have a reasonable likelihood of ultimately requiring RRT.
Inclusion (all must be fulfilled):
1) age ≥ 18 years;
2) admission to intensive care unit (ICU);
3) evidence of kidney dysfunction (serum creatinine ≥100 µmol/L in women and ≥130 µmol/L in men;
4) evidence of severe AKI defined by 1 of the following: i) 2-fold increase in serum creatinine from known baseline or during current hospitalization; or ii) achievement of a serum creatinine ≥354 µmol/L with evidence of a minimum increase of 27 µmol/L from premorbid baseline or during current hospitalization; or iii) urine output <6 mL/kg over the preceding 12 hours.
Exclusion (any of the following results in ineligibility):
1) serum potassium >5.5 mmol/L;
2) serum bicarbonate <15 mmol/L;
3) presence of a drug overdose necessitating urgent RRT;
4) lack of commitment of ongoing life support (including RRT);
5) any RRT within prior 2 months;
6) kidney transplant in preceding 1 year;
7) known advanced chronic kidney disease (CKD) defined by eGFR<20 mL/min/1.73m2;
8) presence or suspicion of renal obstruction, acute glomerulonephritis, vasculitis, thrombotic microangiopathy or acute interstitial nephritis;
9) clinician(s) caring for patient believe that immediate RRT is absolutely mandated;
10) clinician(s) caring for the patient believe that deferral of RRT is mandated.
1) Accelerated (early) RRT initiation (experimental arm): a dialysis catheter will be placed and RRT initiated within 12 hours of the patient becoming fully eligible;
2) Standard (delayed) RRT initiation (control arm): In the absence of kidney function recovery, RRT initiation will be permitted if one or more of the following criteria develop: 1) serum potassium ≥ 6.0 mmol/L; 2) pH ≤7.20 or serum bicarbonate ≤12 mmol/L; 3) hypoxemic respiratory failure, based on P/F ratio ≤ 200 and clinician perception of volume overload; and/or 4) persistent AKI >72 hours following randomisation. Once criteria are fulfilled and/or a decision is made to initiation RRT, a dialysis catheter will be placed and RRT started as soon as possible. There is no obligation to start RRT in the standard arm. All other aspects of RRT (i.e., modality, dose, anticoagulation etc.) for both arms will follow current best practice and local standards.
All-cause mortality at 90-days.
RRT dependence at 90-days; composite of death/RRT dependence at 90-days; major adverse kidney events (MAKE) at 90-days; ventilator-free days through day 28; ICU-free days through day-28; hospital-free days through day-90; death in ICU, 28-days, in-hospital and 1-year; health-related quality-of-life (EQ-5D-5L) at 90-days and 1-year; healthcare costs and incremental cost-effectiveness ratio through 1-year.
Analysis: Primary analysis will follow the principle of intention-to-treat.
Start date: Active.
Duration: 36 months
Estimated completion study date: December 2019
How do I participate?
To participate, please contact Sean M Bagshaw and Ron Wald (Co-Principal Investigators) from the Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta (Canada) Email: email@example.com and firstname.lastname@example.org
• BEARDS Study – Incidence of dysynchronous spontaneous Breathing Effort, breath-stacking and reverse triggering in early ARDS
This project, initiated by the ESICM PLUG (Pleural Pressure) Working Group, is an observational multicentre physiological study that will be conducted in several ICUs in different countries.
In this study we aim to assess the incidence, physiological and clinical consequences of spontaneous breathing effort, dysynchrony and reverse triggering at the early phase of ARDS in continuously sedated patients and at the time of transition to partial ventilatory support.
1) To describe the incidence of spontaneous breathing efforts, reverse triggering (either inducing double cycles or associated with eccentric contractions during expiration), breath stacking and short cycles (with a potential for eccentric contractions of the respiratory muscles), as well as other asynchronies like wasted efforts.
2) To analyse the presence of main dysynchronies (including reverse triggering) withits corresponding changes in transpulmonary pressure swings, plateau pressure and volume delivered by the ventilator in those breaths, and quantify the breathing efforts generated
3) To associate the occurrence of dysynchronies (including reverse triggering) during the early phase of ARDS with outcome (ventilator free days, intensive care unit (ICU) stay, mortality, pneumothorax as secondary outcome).
4) Understand the relationship between sedation levels and regimens and the different types of dysynchronies.
Mechanically ventilated patients under continuous sedation will be considered for enrolment in the first week of ARDS diagnosis.
· Moderate and severe ARDS according to the Berlin definition (11, 12)
· Continuous intravenous sedation
· Deep sedation: Richmond Agitation Sedation Scale (RASS) < or equal -2
Non inclusion criteria
· <18 years
· Patients with a significant bronchopleural fistula
Study Start Date
Dr Laurent Brochard
Medical and Surgical Intensive Care Unit
Saint Michael’s Hospital
Toronto, ON, M5G 1X5
Contact BrochardL@smh.ca to request a copy of the protocol.
How do I participate?
Interested sites can contact Laurent Brochard at BrochardL@smh.ca
Click here to visit the WG webpages.
• International Study on NoSocomial Pneumonia in Intensive CaRE – The PneumoINSPIRE study
Head investigator: Despoina Koulenti, 2nd Critical Care Department, Attikon University Hospital, Athens (Greece); Burns, Trauma & Critical Care Research Centre, School of Medicine, The University of Queensland (Australia)
Project start date
The project has started. However, site recruitment is still open and we welcome more sites to join the study. New sites may register and join the study at any time during 2016.
Initiated by the working group on Pneumonia of the ESICM INF Section, the aim of this project is to perform an international multicentre prospective observational cohort study of nosocomial pneumonia in intensive care units (ICUs) worldwide in order to provide up-to-date and comprehensive descriptive data on the diagnosis, microbiology, time course of resolution, management and outcomes in a global ICU population.
– Evaluate the global epidemiology of nosocomial pneumonia in ICU patients, analysing responsible pathogens and resistance pattern by type of pneumonia and geographical region.
-Describe current clinical practice regarding diagnosis and determine the degree of concordance between the diagnosis of nosocomial pneumonia in routine clinical practise and official definitions, including: a) ATS/IDSA 2005 guidelines; b) CDC/NHSN Surveillance Definitions, 2015.
-Identify variable treatment decisions with emphasis on therapeutic schemas, appropriateness and de-escalation decisions and their relation to outcomes.
– Evaluate time course of resolution and identify early predictors of outcome in a large cohort.
– Evaluate nosocomial pneumonia in specific subgroups of critically ill patients (such as, chronic obstructive pulmonary disease [COPD], the elderly, and trauma patients).
– Describe the differences of nosocomial that develop in non-intubated ICU patients versus ventilator-associated pneumonia (VAP).
– Compare the characteristics and outcomes of nosocomial pneumonia in ward patients (that due to deterioration are later on transferred to the ICU) with nosocomial pneumonia in non-intubated ICU patients.
Site selection & population
All ICUs can apply for participation in the PneumoINSPIRE study with consideration to the following requirements: (i) ICUs must agree to collect unit and patient related data onsite; (ii) ICUs agree to transfer the collected data to the coordinating centre; (iii) ICUs must pursue and obtain ethics committee approval or a waiver.
Participating ICUs will collect data from a nominated start date until a minimum pre-specified target of 10 ICU patients with nosocomial pneumonia is reached. The participating ICUs will be allowed to continue recruitment after they have reached the minimum target of 10 patients if they wish to do so, provided that recruitment period of the study is still open.
2016 until December 2017
Contact: Despoina Koulenti
ClinicalTrials.gov Identifier # NCT02793141
• iSOFA – Intestinal-Specific Organ Function Assessment
Lead Investigator: Annika Reintam Blaser, Dept. of Anaesthesiology and Intensive Care, University Of Tartu, Estonia and Center of Intensive Care Medicine, Lucerne Cantonal Hospital (CH) and Martin Poeze, Maastricht University Medical Center, Dept of Surgery/Intensive Care Medicine (NL).
Project Dates: October 2014 – March 2018
Part A: To prospectively evaluate the value of gastrointestinal symptoms alone and in combination with intra-abdominal pressure (IAP), and acute gastrointestinal injury (AGI) grades, as defined by the ESICM Working Group on Abdominal Problems, in prediction of outcome in intensive care patients.
Part B: To determine whether biochemical markers (plasma and urine) of intestinal injury are of additional prognostic value compared to clinical gastro-intestinal symptoms and AGI grades.
The general aim of the project is to develop a five grade score (0-4 points) for assessment of GI function similar to SOFA sub-scores used for assessment of other organ systems.
More info: contact Anika Reintam