Ongoing Projects - Endorsed

• SYNAPSE-ICU -  An international prospective observational StudY on iNtrAcranial PreSsurE in intensive care (ICU)

This project, initiated by the ESICM NIC Section is an international prospective observational study that will be conducted in several ICUs in different countries.

Aims

We aim to recruit >5000 patients in coma (not obeying commands, no eyes opening) after acute traumatic and non-traumatic brain damage admitted to >500 Intensive Care Units (ICUs).

Objectives

The objectives of the study are to explore ICP monitoring variation in practice in order to prioritise uncertainties in the clinical management of critical care patients with acute brain injury and support further collaborative hypotheses based prospective studies.

The study will focus at capturing the following items weighted for aetiology-specific severity of brain injury:

  • The aetiology of brain injury and aetiology-specific indication for ICP monitoring,
  • The definition of ICP thresholds, incidence of high ICP and evolution of high ICP trends,
  • Threshold-based treatment strategies and measurable effects,
  • Burden on NCCU resource utilisation of high ICP,
  • Mortality and long-term outcome measures of neurological disability.

Population target

Inclusion criteria:

  • Admission to ICU following acute brain injury (ABI) both traumatic and non-traumatic:
    • Haemorrhagic strokes, including intracerebral hematoma and subarachnoid haemorrhage,
    • Infective and metabolic encephalopathy and
    • Ischaemic strokes,
    • Traumatic brain injury (penetrating and non penetrating),
    • ICP monitoring.

Study Start Date

In 2017 - Exact date to be confirmed

Principal Investigator

Giuseppe CITERIO
University Milano Bicocca & Hospital San Gerardo, Monza,(Italy)

Draft Protocol (available soon)

Steering Committee

How do I participate?

More information soon.

Contact: research@esicm.org


• STARRT-AKI: STandard versus Accelerated initiation of Renal Replacement Therapy in Acute Kidney Injury 

Aim 

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. 

Design 

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.  

Population 

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.

 

Protocol

 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.

Primary Outcome 

All-cause mortality at 90-days.

Secondary Outcomes 

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.

Planning 

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: bagshaw@ualberta.ca and bhatiash@smh.ca


• BEARDS Study -  Incidence of dysynchronousspontaneous 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.

Aims

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.

Objectives

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.

Population target

Mechanically ventilated patients under continuous sedation will be considered for enrolment in the first week of ARDS diagnosis.

Inclusion criteria:
·         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

In 2017 - Exact date to be confirmed

Principal Investigator

Dr Laurent Brochard
Medical and Surgical Intensive Care Unit
Saint Michael’s Hospital
Toronto, ON, M5G 1X5
Canada

Steering Committee

Protocol

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.

Contact: research@esicm.org


• DIANA Study -  DetermInants of Antimicrobial use aNd de-escalAtion in critical care

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. 

Target 

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.

Study Start Date 

2nd semester of 2016

Principal Investigators:  

Jan J. De Waele, and Liesbet De Bus, Ghent University Hospital, Belgium

Protocol

Steering Committee

National Coordinators

How do I participate? 

REGISTER HERE

More info? Visit the webpage - www.dianastudy.ugent.be

Contact: dianastudy@ugent.be


• VIP1 study: Multinational, multicentre study of outcome of Very old ICU Patients

Background and scope

This study will address the ICU care of the very old, defined as patients ≥ 80 years, admitted to the ICU. The study will be the first large multinational study, with a 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. Outcome will be registered as outcome at ICU discharge and at 30 days. We will also study the feasibility of a very simple frailty index.
 
Recruitment of patients

The goal is to recruit 20 consecutive ICU patients ≥ 80 years, or continue for a 3 month period (whichever comes first). We hope to recruit 100 - 500 ICUs (2,000 - 10,000 patients) in this large epidemiological study. Patient IDs will not be registered, only gender and age (in rounded years).  Each participating ICU must comply with their country's National rules for this type of study.
 
How to record data?

We have a dedicated server at the Department of Epidemiology, University of Aarhus, Denmark, and have created a simple e-crf. It will be easy to enter data both ICU background data and patient data. There are 14 questions, in addition to some ICU background data to be collected before the start of patient recruitment. The links to both data forms are available here.
 
Study start

ICU recruitment will be open in April 2016, with inclusion of patients set to begin in Autumn 2016. Prior, all local/national regulation allowances for collecting data must be met.
 
Organisation

The study origin is the HSRO section in ESICM (chair Hans Flaatten) and the core steering group is: Bertrand Guidet (France); Rui Moreno (Portugal), Dylan deLange (Netherland), Steffen Christensen (Denmark) and Hans Flaatten (Norway). A larger group of contacts from various European countries will coordinate on a National level.

List of National Coordinators

INTERESTED IN REGISTERING YOUR ICU?

Register here.

Contact: Hans Flaatten, Chair HRSO section.


• 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.

Primary objectives

- 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.  
 
Secondary objectives

- 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.

Site recruitment is set to remain open until April 2017 (for countries with national ethics approval, site recruitment will remain open for all the first semester of 2017).

Recruitment period

Registered sites may start patient recruitment at any time during 2016 provided that the relevant local institutional review board approval is obtained or waiver granted. No maximum site targets will be set. Patient recruitment will be open until December 2017.

You may register your interest by completing and submitting the Participant Survey. You shall receive a confirmation email and usually within 48 hours you will receive more information on the study from the Coordination Centre.
 
Contact:  Despoina Koulenti  

ClinicalTrials.gov Identifier # NCT02793141


• End-of-life practices in intensive care units around the world- The Ethicus II study.

Head investigator: Charles SPRUNG, Hadassah Hebrew University Medical Center

Project start date: July 2015

The objectives of this multicentre study are 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.

More information: Contact Charles Sprung


• 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 Start Date: October 2014

Estimated Study Completion Date: 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