• PROTECTION: PRessure suppOrT vEntilation + sigh in a CuTehypoxemic respiratOry failure patieNts
Summary of the rationale
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.
The trial started in July 2017 and is now closed. It was supported partly by ESICM (Clinical Research Award 2016) and by “Ricerca Corrente” of the Policlinico Hospital, Milan, Italy.
Contact: Tommaso Mauri
• BEARDS Study – Incidence of dysynchronous spontaneous Breathing Effort, breath-taking and reverse triggering in early ARDS
Summary of the rationale
This project, initiated by the ESICM PLUG (Pleural Pressure) Working Group, is an observational multicentre physiological study that has been conducted in several ICUs in different countries.
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) with its 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 dysynchronie
Mechanically ventilated patients under continuous sedation will be considered for enrolment in the first week of ARDS diagnosis.
Steering Committee: Tai Pham (Paris); Martin Dres (Paris); IreneTelias (Toronto); Tommaso Mauri (Milan); Jordi Mancebo (Barcelona); Ewan Goligher (Toronto); Giacomo Bellani (Monza); Lluis Blanch (Sabadell); Laurent Brochard (Toronto).
Project Dates: started in 2017. Patient enrollment is now closed.
More info: contact Laurent Brochard
• iSOFA Study – Intestinal-Specific Organ Function Assessment
Principal Investigators: 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).
Summary of the rationale
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.
Project Dates: October 2014 – March 2018
More info: contact Anika Reintam
• DIANA Study – DetermInants of Antimicrobial use aNd de-escalAtion in critical care
Principal Investigators: Jan J. De Waele, and Liesbet De Bus, Ghent University Hospital, Belgium
Summary of the rationale
De-escalation is applied in no more than 15-50% of patients in most studies, and may consist of different components. There may be important differences between hospitals and countries in the use of de-escalation as well as the impact on outcome thereof. Large scale, multi-country studies are currently lacking.
This study from the Infection Section aims to include 2000 patients in whom empirical antibiotics are started. With an estimated de-escalation rate of 35%, we estimate to include 700 patients in whom de-escalation is performed which would allow for a suitable multivariable analysis.
The trial will give us further insights into the actual use of de-escalation in a global sample of patients, inform us about the determinants of de-escalation, as well as describe the impact of de-escalation, taking various potential confounders into account.
Webpage : www.dianastudy.ugent.be
• The Ethicus II study – End-of-life practices in intensive care units around the world
Head investigator: Charles SPRUNG, Hadassah Hebrew University Medical Center
The project started in July, 2015. The objectives of this multicentre study were to observe and describe actual end of life practices in ICUs of several countries, to determine their overall incidence, to document variations in the pattern of practice and to analyze similarities and differences in terms of variables that might explain the findings.
In addition, the ICUs that participated in the ETHICUS study (30 of the original 37 European ICUs have agreed to participate) will be compared to their practice now and trends and/or changes will be studied.
Moreover, the project will mentor and include young intensivists worldwide in this research project and develop a worldwide network of young intensivists interested in clinical research on ethical and end-of-life care issues.
Contact: Charles Sprung
• VIP1 – Multinational, multicentre study of outcome of Very old ICU Patients
Lead Investigator: Hans Flaatten, Insitution: Haukeland University Hospital, Bergen Norway:
This study addressed the ICU care of the very old, defined as patients ≥ 80 years, admitted to the ICU. With more than 5,000 patients recruited , VIP-1 was the first large multinational study, with basis in Europe, to study the frequency of ICU admission in the very old patients, the use of common ICU resources including ICU and hospital LOS.
Publication: The results of this study were published in ICM and Hans Flaatten presented the results at the ESICM Annual Congress Lives2017 in Vienna (Sept.2017). Intensive Care Med. 2017 Dec;43(12):1820-1828.
Contact: Hans Flaatten
• Sentinel Events Evaluation 3 (SEE 3), a Multinational observational study on safety of intrahospital transport in intensive care patients
Lead Investigator: Andreas Valentin, Institution: Rudolfstiftung Hospital, Vienna, Austria
This study aimed to determine the frequency, characteristics, and contributing factors of sentinel events during IHT of ICU patients on a multinational level. Secondary objectives are: i) to assess the impact of organisational, environmental and cultural factors, ii) to identify preventive measures to increase the safety of IHT in ICU patients, iii) to enhance awareness of safety problems during IHT of ICU patients in participating ICUs. Statistical Analysis will include a descriptive analysis and multiple logistic regression.
Publication of results from this study is expected in Autumn 2017.
Contact: Andreas Valentin
• Monitoring resuscitation in severe sepsis and septic shock ‘MORESS’, a prospective randomised multicentre study
Lead Investigator: Xaime García Nogales, Hospital de Sabadell, Barcelona, Spain.
The hypothesis of this study was that haemodynamic fluid resuscitation guided by dynamic parameters will improve outcome in patients with severe sepsis and septic shock.
The principal objective of this study was to demonstrate a (>10%) decrease in mortality in septic patients resuscitated using a dynamic-parameter-based protocol versus a static-parameter-based protocol to guide fluid resuscitation. In addition, it is expected to observe an improvement in the length of the resuscitation time, mechanical ventilation and vasopressor support-free days, ICU and hospital length of stay, organ failure and renal function.
40-60 general ICUs from Europe and Chile participated. All ICUs are closed units with a critical care specialist on hand 24 hours per day, 365 days per year.
• Cardiovascular Monitoring & Management in Austrian, German and Swiss Intensive Care Units – The ICU CardioMan Study
Lead Investigators: Daniel Reuter and Michael Sander
The objective of this multicentre study was to analyse the reality of haemodynamic monitoring and therapy of the critically ill in Austrian, German and Swiss intensive care units. This included acquisition of data on which types of haemodynamic monitoring clinicians have available in their ICU. This study also aimed to investigate which indications lead to therapy decisions and/or extension of haemodynamic monitoring and which parameters serve as therapeutic goals. Additionally, this study investigated how the extension of haemodynamic monitoring guides and modifies therapeutic decisions and strategies in clinical practice.
Link to the related publication:
Funcke S et al. Practice of haemodynamic monitoring and management in German, Austrian, and Swiss intensive care units: the multicentre cross-sectional ICU-CardioMan Study. Ann Intensive Care. 2016; 6: 49. Published online 2016 May 31. doi: 10.1186/s13613-016-0148-2.
• DecoloniSation strategies in Intensive Care
This European-wide multicentre ICU trial aimed to determine the effect and safety of three decolonisation strategies:
– Selective Digestive tract Decontamination (SDD)
– Selective Oropharyngeal Decontamination (SOD)
– Chlorhexidine mouthwash (Oro-CHX)
Primary outcome was the effect of SDD / SOD and chlorhexidine mouthwash on the rate of ICU acquired bacteremia and 28-day mortality. The effect on colonisation rates and presence of multi drug-resistant gram negative bacteria was also evaluated.
Link to the related publication:
Plantinga N, and Bonten M. Selective decontamination and antibiotic resistance in ICUs. Crit Care. 2015 Jun 24;19:259. doi: 10.1186/s13054-015-0967-9.
• PROSAFE – Promoting patient safety and quality improvement in critical care
Lead investigator: Guido Bertolini
Project start date: November 2008 (28 months)
The aim of the project is to promote patient safety and quality improvement in critical care towards a significant reduction of observed mortality rates and economic costs.
Further information at prosafe.marionegri.it
• ASP-ICU – Aspergillus in Intensive Care Units
Lead Investigator: Stijn Blot
Project start date: November 2006 (60 months)
Recent data indicate that invasive aspergillosis must be considered as an emerging and devastating infectious disease in ICU patients even in the absence of an apparent predisposing immunodeficiency. The AspICU project is an international observational web-based survey that aims to collect a large series of ICU patients with either Aspergilluscolonisation or invasive disease, in order to:
– investigate the epidemiology of invasive aspergillosis in ICU patients, and
– to validate a diagnostic algorithm that discriminates colonisation from invasive disease.
• EVIDENCE – Evidence of Infection Prevention in Intensive Care Nurses’ Daily Practice
Lead Investigator: Stijn Blot
Project start date: November 2006 (72 months)
The EVIDENCE-study is a project that aims to evaluate intensive care nurses’ knowledge of evidence-based guidelines for prevention of ventilator-associated pneumonia (VAP), central venous catheter-related infection (CVC) and surgical site infection (SSI) on an international scale by submitting them to an anonymous knowledge test. Results of the knowledge tests will be analysed and used for implementation of targeted educational programmes. Eventually, a website-based e-learning platform, which is accessible for intensive care nurses all over the world, will be developed.
Project’s website: http://www.vvizv.be/Pages/Evidence.php
• SATURN – Impact of Specific Antibiotic Therapies on the prevalence of hUman host ResistaNt bacteria
Lead investigator: MJM Bonten
Project start date: January 2011
SATURN is a cluster-randomised cross-over multi-centre trial of 10 ICUs. Its aim is to assess the effect of mixing vs cycling of antibiotic empiric treatment on gram-negative prevalence in the ICU population.
• CALOR 2003 – Severe heat stroke admitted to ICUs across Europe in August 2003: an observational survey
Lead Investigator: Djillali Annane
Project start date: October 2003 (2 months)
This survey aimed at investigating the number of patients admitted in ICUs for heat stroke across Europe between August 1st and August 20th, as well as determining the prognosis factors and the hospital mortality and morbidity.
• EPIC II – European Prevalence of Infection in Intensive Care II
Lead Investigator: Jean-Louis Vincent
Project start date: 8/05/2007 (1 day)
The impact of hospital infection is greatest in the intensive care unit and an effective response to the problem relies on the availability of up-to-date, adequate epidemiological data. The first EPIC study was performed on April 29, 1992, and allowed the collection of data from more than 10,000 patients in Western Europe.
On May 8, 2007, EPIC II was conducted to provide an updated epidemiological database on infection in the ICU, 15 years after the original EPIC. EPIC II was extended from Europe to the rest of the world and has been a substantial success with more than 2,000 ICUs participating and more than 10,000 patients registered. Such epidemiological information is vitally important in increasing and maintaining awareness of the impact of ICU infection, in developing local and international management policies for infection diagnosis and treatment, and in ensuring adequate resource allocation.
For more information, please consult the website at www.intensive.org/epic2/index.asp
• AKI-EPI – Acute Kidney Injury – Epidemiologic Prospective Investigation
Lead Investigator: Eric Hoste
Project start date: January 2008 (6 months)
The aim of the study is to evaluate the epidemiology and early management of acute kidney injury, according to the RIFLE classification in ICU patients.
Further information can be found at www.akinet.org.
• ETHICATT – Systematic Study of General Ethical Principles Involved in End of Life Decisions for Patients in European Intensive Care Units
Lead Investigator: Charlie Sprung
Project start date: March 2000 (42 months)
Intensive Care Units are an area where moral dilemmas occur daily. Great advances in science and technology are most evident in ICUs where the majority of lives are saved. Unfortunately, there are many ICU patients who remain comatose or in a dying state for weeks or even months due to sophisticated therapies and technologies. This is a major medical, ethical, legal and socio-economic challenge facing the European Union. The average citizen is terrified of spending his or her last days in an ICU hooked up to machines, losing control and in pain. This project will help solve some of these end of life challenges. The present project is a prospective study of the general ethical principles involved in end of life decisions for patients in European ICUs.
Lead Investigator: Charlie Sprung
Project start date: August 2000 (36 months)
The aim of this project was to standardise definitions for foregoing life-support including withholding and withdrawing life sustaining treatments and end of life procedures, incl. euthanasia.
Related publications can be found in ICM.
• EU-VAP/CAP – Pneumonia in Patients requiring mechanical ventilation in European Intensive Care Units
Lead Investigator: Jordi Rello
Project start date: January 2006 (36 months)
The scientific literature includes plenty of articles about the diagnosis and treatment of pneumonia in the ICU. However, the information concerning both the actual clinical practice and the reason for the implementation of such a practice is limited.
The EU-VAP/CAP is the first prospective, observational study that is specifically designed to look at the clinical management of pneumonia in the European ICUs (28 participating ICUs from 9 European countries). The aim of the study was to provide an insight into the current status of CAP/HAP/VAP diagnosis, pathogenic organisms, and therapies in European ICUs, as well as the utilisation of this information as a tool in the effort to improve outcomes.
More than 2,500 patients have been recruited for the study and the interpretation of the collected data is ongoing. Preliminary results were presented in the ATS 2008 International Conference and ESICM CONGRESS in Lisbon.
Further info on the study website: www.euvap.info
• GAINS – Genomic Advances in Sepsis
Lead Investigator: Charles Hinds
Project start date: January 2005 (36 months)
The project is aimed at identifying factors that determine the incidence, severity and the outcome from life-threatening infections (severe sepsis/septic shock) in patients admitted to High Dependency Units (HDUs) or Intensive Care Units (ICUs) with community acquired pneumonia (CAP) or with faecal peritonitis (FP). This will require the acquisition of a large, high quality resource of genetic material (DNA), plasma, urine, white blood cells and clinical information from well-characterised groups of similar patients with, or at risk of, severe sepsis/septic shock. The principal objective is to perform studies that are sufficiently large to establish beyond doubt the influence of a series of selected “candidate” genes on the development, progress and outcome of sepsis.
Further info at the study website: www.ukccg-gains.org
• GLUCONTROL – Comparative effects of two glucose control regiments by insulin in ICU patients
Lead Investigator: Jean-Charles Preiser
Project start date: October 2004 (18 months)
This project, which is now over, aimed at defining whether a tight glucose control by insulin improved the vital outcome in a mixed population of critically-ill patients.
• EUROBEDHEAD – European evidence-based consensus recommendation on bed head elevation policies for mechanically ventilated patients
Lead investigator: Barbara Niël-Weise
Project start date: January 2010
The aim of the project is to turn the scientific evidence of bed head elevation policies in mechanically-ventilated patients into a European consensus recommendation.