Ongoing Projects – Endorsed

Ongoing Projects – Endorsed

Last updated : 06/01/2025 - 574 views

• The criticAl Care nUtrition mulTinational rEgistry “ACUTE”

Aims:
This is a multinational multicentre registry implemented in adult ICUs, where nutrition data will be prospectively collected and retrospectively analysed. Worldwide adult ICUs are invited to participate in this project. This project is an initiative supported by the ESICM FREM Section.

FOR MORE INFORMATION, PLEASE CONTACT Christian Stoppe, Department of Anesthesiology, Intensive Care, Emergency and Pain Medicine University Hospital Wuerzburg; Department of Cardiac Anesthesiology and Intensive Care Medicine German Heart Center Charité Berlin, Germany christian.stoppe [ @ ] gmail.com   

• Can pulse pressure assessment at the bedside detect low values or track changes of stroke volume in critically ill patients? The multicenter, cross-sectional, observational –  “ANDROMEDA-PEGASUS”

Aims:
This multicenter, international, investigator-led, cross-sectional observational study aims to assess the predictive capacity of pulse pressure (PP) to detect low stroke volume (SV) as evaluated by bedside ultrasonography in critically ill patients. Secondary objectives include: To assess the predictive capacity of PP to detect low SV in different clinical contexts in ICU patients, such as in those with acute respiratory distress syndrome (ARDS), postoperative states, or septic shock, among others. To assess the impact of several demographic, clinical and technical issues on the predictive capacity of PP to estimate SV, such as mechanical ventilation, vasoactive medication, age, position of the arterial line, among others. To determine the capacity of PP to track changes of SV during common intensive care interventions such as passive leg raising (PLR) maneuver, fluid challenges, vasoactive drug initiation or titration.

FOR MORE INFORMATION, PLEASE CONTACT Glenn Hernandez and Eduardo Kattan, Co-chairs of the Project (both ESICM members), Departmento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile. glennguru [ @ ] gmail.com   

• Sepsis in the ICU-II: Precision medicine models for sepsis-induced myocardial dysfunction – “SICU II”

Aims:
To determine the association between left and right ventricular systolic and diastolic dysfunction (Aim 1), novel biomarkers (Aim 2) and adverse outcome in SIMD. Finally, we will determine the combined value of clinical, biomarker, echocardiographic, and haemodynamic variables (Aim 3). Adverse outcomes are defined as acute myocardial injury (Effect 1), days free of organ support (Effect 2), 30-day mortality (Effect 3) and days alive and out of hospital at 30 days after ICU admission (Effect 4). We will use traditional statistical inference based on standard multivariable and mixed model analysis to explore the prognostic significance of individual and combined predictor variables.
(2) A machine learning algorithm to identify important features for prediction of short- and long-term mortality: To use an ensemble tree-based machine learning approach to identify the most important features (i.e. variables), among a set of supplied features, that can predict mortality, and examine how each feature alters the prior expectation of ICU outcome (Aim 4, Effect 5).
(3) Consensus definition of sepsis-induced myocardial dysfunction: Combining the results of our studies with current literature, we will invite key opinion leaders within the field to formulate a consensus for the definition, management and future research priorities for SIMD (Aim 5).

FOR MORE INFORMATION, PLEASE CONTACT Michelle Chew Dept of Anaesthesia and Intensive Care, Linköping University Hospital, S58185, Sweden. Michelle.chew [ @ ] liu.se   

• PeriOPerative OUTcome Platform Study – “POP-OUT”

Aim:
Regarding the objectives of the first study within the platform entitled: Association of intraoperative Hemodynamic characteristics with postoperative Complications and Mortality (HeCoMo).  Hypothesis: The hemodynamic characteristics like amounts of intravenously administered fluids, vasopressors, or inotropes are associated with increased postoperative complication rates and severity as well as postoperative mortality.
– Primary: Short-term postoperative complications according to the Clavien-Dindo classification greater or equal to IIIb
– Secondary: Postoperative mortality (in-hospital, 3-months, one-year).

FOR MORE INFORMATION, PLEASE CONTACT Aarne Feldheiser a.feldheiser [ @ ] kem-med.com  Dept. of Anaesthesiology, Intensive Care Medicine & Pain Therapy, Evang. Kliniken Essen-Mitte, Huyssens-Stiftung/Knappschaft, 45136 Essen, Germany.

• Cerebrovascular Investigation Related to Circulatory parameters Using Longitudinal Assessments on Transcranial Doppler based Evaluation in Mechanical Circulatory Support. Circulate MCS study

Aim:
Primary Aim: To characterize the relationship between all Transcranial Doppler(TCD)-derived cerebral blood flow(CBF) parameters ( mean blood flow velocity, pulsatility index and autoregulation index) with different systemic flow patterns in Mechanical Circulatory Support(MCS) (type of device, degree of support, native cardiac output, vasopressor/inotrope use, pulsatile vs non- pulsatile, different flow volumes, varied peak flow rates, resistance of systemic circuit measured with pulsatility Index) and develop reference ranges adjusted to age, gender, race, comorbidities & extracranial carotid values.
Secondary aim: To identify the association of individual TCD-derived parameters adjusted for MCS settings, age, gender, race, co-morbidities with adverse neurological events in critically ill patients receiving MCS

FOR MORE INFORMATION, PLEASE CONTACT AArti Sarwal 3160 Allerton Lake Drive, Winston Salem, NC (USA) aartisarwal [ @ ] gmail.com +1(573) 823-5878

• Core outcome set of daily monitoring of gastrointestinal function in critically ill patients. The COSMOGI Study

Aim:
The purpose of this study was to reach consensus on:
(1) the core outcome measures that should be reported daily in trials assessing
gastrointestinal function or nutrition in critically ill patients.
(2) the definitions of these outcomes.

FOR MORE INFORMATION, PLEASE visit https://cosmogi.site/ and CONTACT:

Kaspar Bachmann, Department of Anaesthesiology and Intensive Care
University of Tartu, Tartu, Estonia kaspar.felix.bachmann [ @ ] ut.ee

Bethan Jenkins, University Hospital Southampton NHS Trust
Southampton General Hospital Bethan.jenkins [ @ ] uhs.nhs.uk

Publication:  Bachmann et al. Critical Care (2024) 28:420
https://doi.org/10.1186/s13054-024-05192-8

• Prospective, multicenter study to validate the GastroIntestinal Dysfunction Score (GIDS) and describe prevalence, outcomes, and management of phosphate disorders in intensive care patients (the GUTPHOS study).

Observational, prospective, multicentre trial. This study does not include any intervention, routine practice in participating sites is observed.

Objectives

Aim 1: To validate the Gastrointestinal Dysfunction Score in predicting mortality and duration of ICU dependency and duration of PN dependency among consecutive adult patients admitted to participating ICUs worldwide.
Aim 2: To identify the prevalence, management practices, and outcomes of Pi abnormalities during the first week of ICU admission in consecutive adult patients admitted to ICUs worldwide.

Recruitment of sites and target population

We aim for 20 ICUs to include adult patients (≥18 y) admitted to ICU during recruitment period. Exclusion criteria: restrictions of care at ICU admission; admitted for treatment as organ donors; continuous chronic home ventilation for neuromuscular disease; declined participation or informed consent; or readmission to ICU during the study period.

Funding: This project received the 2023 ESICM Fresenius Kabi Clinical Nutrition Award.

FOR MORE INFORMATION, PLEASE CONTACT:

Arthur van Zanten, Gelderse Vallei Hospital, Ede, The Netherlands zantena [ @ ] zgv.nl
Annika Reintam Blaser,  University of Tartu Hospital, Tartu, Estonia annika.reintam.blaser [ @ ] ut.ee

• Use of Non-Invasive Methods for Intracranial Pressue (ICP) Monitoring in Traumatic Brain Injury when invasive ICP is not available (in Low and Middle Income Countries). The MINIMAL Study

Use of Non-Invasive Methods for Intracranial Pressure (ICP) Monitoring in Traumatic Brain Injury when invasive ICP is not available (in Low income countries). The Minimal TBI study.

Aim:
To develop a consensus and clinical guidance for clinicians who face TBI patients when invasive ICP is not available and using non invasive ICP tools such as transcranial doppler, automated pupillometer and ultrasonographic assessment of optic nerve sheath diameter.

Panel

The panel will be composed by 19 physicians (neurointensivist and neurosurgeons) from high income countries with high experience on management of TBI with invasive and non invasive tools, and 20 physicians ( neurointensivist and neurosurgeons) from low income countries who manage every day TBI patients without invasive ICP from all over the world.

Expected results:
We expect to obtain a number of statements which will be able to guide clinicians in the use of non invasive methods to estimate ICP to treat TBI patients, together with clinical assessment and neuroimaging. We hope that especially in low income countries, this will improve the level of care and the treatment of these patients. The literature search will also offer the possibility to assess the presence of literature and knowledge gaps, which can guide for the development of large multicenter studies on this topic.

Members of the Steering Committee:

Chiara Robba,University of Genoa,Italy
Andres Rubiano, Neuroscience Institute, INUB-MEDITECH Research Group, El Bosque University, Bogotá, Colombia
Fabio Taccone, Erasme University, Bruxelles, Belgium
Geert Meyfroidt, Leuven University,Leuven, Belgium

FOR MORE INFORMATION, PLEASE CONTACT:

Chiara Robba,University of Genoa, Chair of the ESICM NIC Section kiarobba [ @ ] gmail.com

• A European Survey on MIgRAnts in the Intensive Care Unit – The AMIRA Study

A prospective observational study in 100 ICUs from 10 European countries. A 1 week survey performed 4 times over a 1-year period.

Study population:
Non-national patients residing in the recruiting center country will be defined as migrants. Non-migrants will be considered as belonging to the general population.
Among migrants, sub-groups will be defined a priori:
– Documented migrants: regularly living according to the country’s laws concerning immigration
– Asylum seekers: patients than have filled in an asylum demand
– Refugees: patients that benefit from a refugee status
– Undocumented migrants: patients living irregularly in the country
– Undocumented migrants, asylum seekers and refugees (UMASR) will be compared to documented migrants and to general population (control groups).

Methods and Analysis:

Design: multicentric prospective observationnal study.
Participating Centers: 100 European ICUs in the 10 European countries where immigration was the most important in 2019 (Germany, France, Spain, Greece, United-Kingdom, Italy, Belgium, Sweden, Netherlands, Finland).
Study periods: 4 time one week period (1 week / season at predetermined dates) over 1 year.
Study groups: UMASR, documented migrants and general population.
Non-national patients residing in the recruiting center country will be defined as migrants. Non-migrants will be considered as belonging to the general population. Documented migrants and UMASR will be analyzed separately. Patients will be classified according to their affiliation to the national healthcare system and administrative informations recorded at hospital admission.
Timing:
This study Starting date: 2023
Study Duration: 12 months (it can be extended on request)

Expected result:
This endorsed study will describe the characteristics of UMASR admitted to the ICU (demography, economic and social context, comorbidities, reason for admission, need for invasive support during ICU stay), their outcomes (ICU and hospital survival) compared to general population and documented migrants. To have an insight into the practices related to communication with the patients and his relatives considering language barrier and cultural/religious differences and to end of life process.

FOR MORE INFORMATION, PLEASE CONTACT:

Sami HRAIECH Medical ICU, APHM, Marseille France, Aix Marseille University
Elie AZOULAY, Medical ICU, APHP, France, Paris University

sami.hraiech [ @ ] ap-hm.fr; elie.azoulay [ @ ] ap-hp.fr

• ReLatIonship BEtween implementation of evidence-based and suppoRtive ICU cAre and ouTcomes of patIents with acute respiratOry distress syndrome – The ICU LIBERATION Study

Aim: This study aims to investigate the epidemiology and treatments given to the patients and evaluate the implementation of evidence-based ICU care and its association with the outcomes of patients with ARDS admitted to the ICU. The contents of mechanical ventilation settings, respiratory conditions, and evidence-based ICU care, such as analgesia, sedation, rehabilitation, and nutrition, given to the patients will be collected on a daily basis to perform a robust statistical analysis.

Methods and Analysis: This study will be a prospective observational study, with case enrollment beginning after Ethics Committee approval during the patient enrollment period. Up to 10 patients who meet the inclusion and exclusion criteria will be enrolled in the central online database. Upon admission to the ICU of patients who meet the selection criteria, the principal investigator or collaborator at each collaborating institution will assess their suitability for the study.

Timing:
This study Starting date: June 2023
Study Duration: 60 months (it can be extended on request)
Patient enrollment period: June 2023 to May 2024 (12 months)

Expected result:
This ESICM-endorsed study will reveal the epidemiological outcomes and PICS related-outcomes of ARDS on a large scale. Furthermore, this registry will demonstrate how ICU-ventilated patients with ARDS receive the treatments and evidence-based ICU care during their ICU stay on a daily basis in detail.

FOR MORE INFORMATION, PLEASE CONTACT:

Check for more details on the study webpage here

or contact the research office at liberation-office [ @ ] googlegroups.com

To take part in the project, please register here

  1. CRF
  2. Protocol
  3. Study explanation sheet
  4. Consent form
  5. Data sharing – authorship secondary analysis
  6. Application form for secondary analysis
  7. Confidentiality Agreement
  8. Ethical approvalAmendment 1Amendment 2

Stefan Schaller, Deputy Clinical Director, Department of Anesthesiology and Operative Intensive Care Medicine (CVK, CCM), Charité – Universitätsmedizin Berlin, Germany.

• Use and management of non-invasive methods to assess intracranial pressure in Traumatic brain injured patients in Low & Middle Income Countries (+ in High Income Countries when there are contraindications to invasive methods): a consensus and clinical recommendation  (USEFUL)

Aim of the consensus: to establish the role and use of non invasive methods for the estimation and management of intracranial pressure, in a context where invasive methods are not available, in particular in low-middle income countries. The consensus will provide a number of recommendations regarding the use of different methods (pupillometer, Transcranial Doppler,optic nerve sheath diameter, Computed Tomography), and a decisional practical algorithm.

Methods and Analysis: Systematic review with GRADING of literature, and Delphi process for the votation of the recommendations.

A panel including 29 experts from all over the world, considering gender diversity and representation of low/ high income countries representatives will be created. An expert methodologist (Nancy Carney) will supervise the literature search, GRADING and the steps of the Delphi process..

Expected result:
The group expects to clarify the importance and role of non-invasive methods assessing intracranial pressure and to provide to clinicians a number of recommendations and practical suggestions for the clinical management of traumatic brain injured patients in a context where invasive ICP is not available.

FOR MORE INFORMATION, PLEASE CONTACT:

Chiara Robba (Italy) at kiarobba [ @ ] gmail.com and Andres Rubiano (Colombia) at rubianoam [ @ ] outlook.com

• Prone positioning for invasively ventilated patients with COVID-19: an interactive, web-based, multicenter, observational registry (PROVENT)

PRIMARY and SECONDARY OBJECTIVES:

The primary objective of this study is to define potential clusters of critically ill patients – treated with PP – that are homogeneous in terms of both clinical and treatment characteristics.

The Secondary objectives of this study are:
1) To assess the association between cluster membership and positive short-term outcome (i.e. an improvement in respiratory parameters)
2) To assess the association between cluster membership and positive long-term outcomes, defined here as 28days ventilator free days and patient survival at ICU discharge
3) To describe oxygenation, assessed by PaO2/FiO2 ratio, before and after each PP manoeuvre
4) To describe the clinical circumstances under which clinicians opt for PP
5) To describe PP utilization rates in intensive care units in Italy
6) To describe PP in terms of treatment duration in intensive care units in Italy
7) To describe PP in terms of treatment timing in intensive care units in Italy
8) To investigate the impact of time of prone position ventilation on PaO2/FiO2 ratios after each PP cycle and on days free form ventilation
9) To investigate the impact of PP on renal outcome

DESIGN and POPULATION:

This is an international, multicenter, non-profit, retrospective and prospective observational cohort study. The study is non interventional. Study duration is one year.  We anticipate to finalise the study in May 2022.

Inclusion Criteria and exclusion criteria can be found in the protocol hereunder.

STUDY START DATE
The project is currently recruiting.

FOR MORE INFORMATION, PLEASE CONTACT THE PI:

Silvia De Rosa, Anesthesia and Critical Care Unit, San Bortolo Hospital, Vicenza, Italy, derosa.silvia [ @ ] ymail.com or  ricerca [ @ ] siaarti.it

The Steering Committee members are: Paolo Navalesi, Giorgio Fullin, Dario Gregori, Mario Peta, Daniele Poole, Fabio Toffoletto, Giacomo Bellani, Giuseppe Foti, Francesco Papaccio, Tommaso Pettenuzzo, Emanuele Rezoagli, Nicolò Sella.

Download the Protocol (version of June 2021)

PRone positioN in patients with spontanEous ventiLation and acute hypoxemic respIratory FailurE (PRONELIFE)

PRIMARY OBJECTIVE:

The primary endpoint is a composite of tracheal intubation and all-cause mortality in the first 14 days after enrolment.

SECONDARY OBJECTIVES:

  • Mortality at day 14
  • Intubation among survivors at day 24
  • Effects on oxygenation defined by the SpO2
  • Days under the oxygen support device
  • Time to tracheal intubation
  • Related complications. The following will be considered complications associated to the prone position:

o Oxygen desaturations (SpO2 <90%)
o Episodes of hemodynamic instability (BPsys < 90mmHg or BPsys drop > 10mmHg if BPsys < 90 before the maneuver)
o Need of orotracheal intubation
o Cardiac arrest
o Displacement of the non-invasive respiratory support device
o Removal of central venous line, if documented
o Displacement of an arterial line, if documented
o Displacement of a urinary catheter, if documented

  • Respiratory rate
  • Dyspnea defined according to the Borg dyspnea scale (APPENDIX v)
  • Duration of invasive mechanical ventilation in those patients who required intubation
  • Ventilation-free days (VFD) at 28 days from ICU admission, defined as the number of days alive and free from IMV during the first 28 days from start of IMV
  • ICU-free days and hospital-free days at day 90
  • Mortality at day 28 and day 90

 

Design

Pragmatic, investigator–initiated, international, multicenter, parallel randomized clinical two–arm trial on acute hypoxemic respiratory failure patients with a respiratory rate of more than 25 breaths per minute, SpO2 < 94% and FiO2 of at least 40% or more by either Venturi facemask, HFNC or NIV/CPAP and, absence of decompensated respiratory acidosis.

Population

We intend to recruit acute hypoxemic respiratory failure patients with a respiratory rate of more than 25 breaths per minute, SpO2 < 94% and FiO2 of at least 40% or more by either Venturi facemask, HFNC, or NIV/CPAP and, absence of decompensated respiratory acidosis during two years. Currently, we expect about 35 centers to participate in the trial.

Demographic data and clinical characteristics on screened patients, regardless of enrolment criteria match, will be recorded (registry). We will randomize 650 patients admitted to the participating centers’ intensive care units and expect each participating center to randomize at least 25 patients who meet all inclusion criteria.

Study Timeline

The total trial duration will be 48 months. The total recruitment period will last for 2 years with a follow-up of 3 months, based on a recruitment rate of 75% for each center. There will be 3 months at the end for final data analysis, reporting and trial close down..

Study start date and Registration

The project aims to start in 2021.
We wish to involve medical professionals from 40 ICUs and 650 patients.

Principal Investigator – Contact

Luis Fernando Morales-Quinteros
Hospital Universitari de Sant Pau, Barcelona, Spain
Institut d’Investigació i Innovació Parc Taulí, Sabadell, Spain luchomq2077 [ @ ] gmail.com

Steering Committee

Luis Morales-Quinteros, Marcus J Schultz, Ary Serpa-Neto, Massimo Antonelli, Domenico L. Grieco, Oriol Roca, Nicole Juffermans, Lluis Blanch, Candelaria de Haro, Diego de Mendoza, Marta Camprubi-Rimblas, Antonio

Download the final protocol here (update 6 Sept.2021). Details on the primary and secondary outcomes here.