• 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)

• Development of a core measurement set for studies of interventions to enable communication in adults requiring an artificial airway with or without mechanical support 

Communication with an artificial airway – a Core Outcome Set (COS)

PRIMARY and SECONDARY OBJECTIVES:

We aim to develop international key stakeholder consensus on a COS for studies of interventions designed to enable communication in adults requiring an artificial airway with or without mechanical ventilator support irrespective of care location.

Our specific objectives are to:

  1. Characterise selection and definition of outcomes and measures used in existing studies of interventions designed to enable communication in adults requiring an artificial airway with or without mechanical ventilatorsupport;
  2. Identify outcomes of importance to end usersof communication aids (patients and family); and
  3. Obtain consensus on a COS for future studies of interventions designed to enable communication in adults requiring an artificial airway with or without mechanical ventilator support.
  4. Develop set of measurement tools to measure COS.

DESIGN and POPULATION:

To achieve our objectives we will use methods outlined in the COMET handbook and those endorsed by the COMET initiative.

To achieve our objectives we will use methods outlined in the COMET handbook and those endorsed by the COMET initiative:

Phase 1: Patient/Family Interviews
Phase 2: Delphi Consensus Building Exercise
Phase 3: Consensus Meeting conducted online via Zoom
Phase 4: Instruments to Measure Outcomes

Inclusion Criteria

  1. Adults with, or had an artificial airway within the last 3 years, and/or communication partners of an individual with an artificial airway;
  2. Able to understand, read, and communicate inEnglish;
  3. Access to a telephone and the internet; and
  4. Consent to participate.
  5. Clinician/researcher criteria for participation in the Delphi for listing:
    • Patients, communication partners, and patient user/support group representatives;
    • Expert clinicians (physicians, nurses, speech pathologists, and other allied health professionals); and
    • Researchers in communication aids.
  • Exclusion Criteria
    1. Currently admitted to an acute care hospital setting.

STUDY START DATE
The project is currently recruiting.

FOR MORE INFORMATION, PLEASE CONTACT THE Co-PIs:

Prof. Louise Rose, RN, PhD – ESCIM member.Professor of Critical Care Nursing, Florence Nightingale Faculty of Nursing, Midwifery, and Palliative Care.King’s College London,London, UK.

Dr Amy Freeman-Sanderson PhD, CPSP. Graduate School of Health, University of Technology, Sydney, NSW, Australia.Royal Prince Alfred Hospital, Sydney, NSW, Australia .Critical Care Division, The George Institute for Global Health, Sydney, NSW, Australia .Senior lecturer Speech Pathology.University of Technology Sydney.

Downloads:  Plain Language Summary COS, ETH21-5966 Recruitment emails, ETH21-5966 PIS Phase2 Delphi Clinicians Approved

• Core Outcome Measures for Clinical Effectiveness Trials of Nutritional and Metabolic Interventions in Critical Illness 

An international Modified Delphi Consensus Study (CONCISE) 

PRIMARY OBJECTIVE:

To undertake a modified Delphi consensus process, selecting a core set of patient function outcome measures that should be reported in clinical effectiveness trials of nutritional and metabolic interventions in the critically ill population.

DESIGN and POPULATION:

Modified Delphi methodology to reach consensus on a core set of outcome measures

  • Inclusion criteria:
  • Adults over 18 years of age who are critically ill
  • Intervention: Any nutritional or metabolic intervention delivered during critical illness including enteral and parenteral nutrition
  • Context for use: Primarily for adoption in all research trials and clinical studies evaluating nutritional and metabolic interventions in in critical illness

STUDY START DATE and REGISTRATION:
The project aims to start in 2021

We wish to involve medical professionals from >50__ICUs and _100__patients.

Register your ICU here

Duration: 3 months per round, to a maximum of 9 months (it can be extended on request)

MORE INFORMATION and CONTACT:

Zudin Puthucheary, M.D., Ph.D.,Critical Care and Perioperative Medicine Research Group, Queen Mary University London, London, UK

Members of the Steering Committee:

Michael Hiesmayr, Kenneth Christopher, Jan Gunst, Michael Casaer, Marcel Van De Poll, Rob Van gassel, Jean-Charles Presier, Aileen Hill, Angelique Deman, Kursat Gundogan, Annika Reintam-Blaser, Anne-Francoise Frousseau, Carol Hodgson, Lee-Anne Chapple, Linda Denehey, Melina Castro, Pierre Singer, Carla Sevin, Zheng Yii

Download the protocol  here (version  of 15 March 2021)

• SKin and soft tissue necrotizing INfections in the Intensive Care Unit: a prospective multi-national cohort study

SKin and soft tissue necrotizing INfections in the Intensive Care Unit: a prospective multi-national cohort study 

PRIMARY OBJECTIVE:

To assess hospital (e., ICU and hospital mortality) and medium-term (day-90 and day-180 mortality, functional outcomes and health-related quality of life scores) outcomes.

SECONDARY OBJECTIVES:

To report the clinical presentation and microbiological epidemiology of NSTI and identify independent prognostic factors of mortality and altered quality of life.

DESIGN and POPULATION:

Multinational prospective non-interventional cohort study

  • Inclusion criteria:
  • Age > 18 years
  • Non-opposition to participate in the study
  • Patient with surgically-confirmed NSTI (i.e., macroscopic appearance of tissue during surgery revealing swollen, dull gray tissues with a thin, brownish exudate with or without necrosis)
  • Exclusion criteria: none

STUDY START DATE and REGISTRATION:
The project aims to start in 2021
We wish to involve medical professionals from > 100 ICUs and include 1033 patients
Register your ICU here

MORE INFORMATION and CONTACT:

Nicolas de Prost, M.D., Ph.D., Medical Intensive Care Unit, Hôpital Henri-Mondor, Assistance Publique-Hôpitaux de Paris, Créteil, France and Groupe de Recherche Clinique CARMAS, Université Paris Est Créteil, Créteil, France nicolas.de-prost@aphp.fr 

Members of the Steering Committee:

Olivier Chosidow, M.D., Ph.D., Department of Dermatology, Hôpital Henri-Mondor, Assistance Publique-Hôpitaux de Paris, Créteil, France. Olivier.chosidow@aphp.fr

Christian Eckmann, M.D., Ph.D., Department of General, Visceral and Thoracic Surgery, Klinikum Hannoversch-Muenden, Center for Research in Surgicasl Infections, Academic Hospital of Goettingen University, Hannoversch-Muenden, Germany. chr.eckmann@gmx.de

Martin Bruun Madsen, M.D., Ph.D., Department of Anaesthesiology and Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. martin.bruun.madsen.01@regionh.dk

Tomas Urbina, M.D., Medical Intensive Care Unit, Hôpital Saint-Antoine, Assistance Publique-Hôpitaux de Paris, Paris, France. tomas.urbina@aphp.fr

Jan de Waele, M.D., Ph.D., Department of Critical Care Medicine / Surgical Intensive Care Unit, Ghent University Hospital, Gent, Belgium. Jan.DeWaele@UGent.be

We are looking for National Coordinators (NC): Please contact Nicolas De Prost

Download the protocol  here

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.

• Toxic-Europe. The Outcome of Intoxicated ICU Patients in Europe

Why

Patients with serious intoxications are admitted to the ICU for surveillance, because the time of maximum toxicity is often difficult to predict. However most patients admitted for an intoxication in the ICU have a short duration of stay and a low mortality compared to other ICU patients. The TOXIC-Europe study will provide new insights in early triage of patients with severe intoxications that could lead to more efficient care at ICUs.

Aim

To assess the incidence, severity and clinical consequence of patients with acute intoxications at intensive care units (ICU) in Europe.

Design

International, multicentre, prospective, observational cohort study.

Population

ICU adult patients admitted from an emergency room (ER) or ward with an acute intoxication as primary reason of admission and an ICU stay of more than 4 hours.

Objectives

To describe current rates of eventful admission defined as having received intensive treatment within 24 hours after ICU admission with patient and intoxication characteristics.

To describe complications, length of ICU and hospital stay, length of treatment, time to limitation of first life sustaining treatment and in-hospital or 30-day mortality.

To assess current clinical practice of handling acute intoxications, treatment decisions and their relation to outcome across geographical regions.

To identify early predictors of outcome including intoxication specific indicators such as ECG factors for cardiovascular toxicities.

To develop a prognostic model that predicts a complicated course for patients with an acute intoxication.

Study start date and Registration

The project started in 2020 and site recruitment is open. We welcome more sites to join the study. You can register your ICU at our website: https://toxicstudy.org/

We are looking for National Coordinators

We call out  for national coordinators to support the conduct of TOXIC-Europe within their country. You can register at our website: https://toxicstudy.org/

Principal Investigators

Claudine Hunault
Samanta Zwaag
Dylan de Lange

Steering Committee

Barbara Borgatta (also National Coordinator for the UK)
Maurizio Cecconi
Hans Flaatten (also National Coordinator for Norway)
Bertrand Guidet
Christian Jung (also National Coordinator for Germany)
Bruno Mégarbane (also National Coordinator for France)
Rui Moreno (also National Coordinator for Portugal)
Andrew Rhodes

Contact

Claudine Hunault
Phone: +31 88-755 8561
E-mail: contact@toxicstudy.org

More information including the study protocol and ethical essessment(s) can be found at https://toxicstudy.org/ 

 

• Corona Virus disease (COVID19) in Very Elderly Intensive care Patients (VIPs): COVIP study

The COVID-19 pandemic is threatining numerous countries worldwide. Preliminary reports of critically ill COVID-19 patients in Wuhan (China) and Italy reported a high risk of death in patients with multimorbidity. Also, very old patients with SARS-CoV-2 infections suffered from high mortality rates (1). It is, however, unclear if age alone is an independent risk factor, or if co-morbid conditions and frailty trigger the adverse outcome. During the pandemic, treating and triaging elderly COVID-19 may challenge our health care systems.

COVIP study is a European multicenter study of outcomes and prognostic factors in coronavirus disease (COVID-19) in very old intensive care patients. This international, multicenter study group (VIP-network) will conduct a prospective, observational study to examine the relationship between age, co-morbidities, pretreatment frailty and outcomes in a group of elderly patients receiving critical care for COVID-19.

The coronavirus SARS-CoV-2 is currently affecting thousands of patients across many countries and there is an urgent need to investigate patient characteristics and outcome trajectories.

The VIP network which has previously (2016-2019) conducted the most extensive prospective studies (VIP1VIP2) on elderly ICU patients, is immediately deploying this study of elderly COVID19 patients.

The results will be essential to understand which factors can predict mortality in elderly COVID-19 patients to help to detect these patients early. Furthermore, this study will also be a knowledge base necessary to guide triage decisions in the future.

Register your ICU:

Click  to register your ICU here

Documents:
More information:

Please check the following website: https://vipstudy.org/

(1) Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, et al. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020.

• Multicenter ObserVational Study on PracticE of VeNTilation In Brain Injured PAtIeNts: VENTIBRAIN

 

Rationale :

Several experimental and clinical studies have shown how brain injury can cause secondary lung injury. Lung injury could be due either to mechanical ventilation- often necessary in brain injured patients- or to inflammatory response that follows primary acute brain injury. The concept of ‘Protective lung ventilation’ has shown to reduce morbidity and mortality of intensive care unit (ICU) patients with acute respiratory distress syndrome (ARDS) but seems also to have a beneficial effect on patients with healthy lungs and in the perioperative settings. However, these recommendations often come into conflict with the management of patients affected by acute brain injury, in which permissive hypercapnia and increased intrathoracic pressure as consequence of protective ventilation strategies can be dangerous.

Objective :

This observational study aims to determine the ventilation practice of consecutive intubated and ventilated neuro-ICU patients in the first week from admission in intensive care units.

1. Primary objective is to determine ventilation settings of intubated and mechanically ventilated neurocritically ill patients admitted to the ICU.
2. Secondary objectives are:

    • The association of ventilator settings and targets with outcome in the whole population
    • The differences in ventilator settings among different countries
    • To assess the incidence of pulmonary complications (including pneumonia, ARDS, neurogenic pulmonary edema) in this cohort of patients.
    • To assess the ventilator settings applied when intracranial pressure is raised (>20 mmHg).

Study design:

This is an international multi–center prospective observational study.

Study population:

This study will include all consecutive brain injured patients (traumatic brain injury (TBI) or cerebrovascular) intubated and ventilated in ICU and observed for a 7–day period.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Seen the observational design of the study, there is no patient burden. Collection of data from ICU and hospital charts and/or (electronic) medical records systems is of no risk to patients.

Ethical committee:

Documents for applying to the Ethical committee will be provided in few months.

Please check IRB/ethical committee approval process locally.

Participation and contact: 

If you are interested, please contact Dr Chiara Robba or ventibrain@gmail.com

Core Steering Committee: 

Chiara Robba (Principal Investigator)
Paolo Pelosi
Giuseppe Citerio
Fabio Taccone

Extended Steering Committee :

Jordi Mancebo
Robert Stevens
Geert Meyfroidt
Mauro Oddo
Rafael Badenes (NC Spain)
Valentina Della Torre (NC UK)
Reymund Helbock
Jose’ Suarez
Nino Stocchetti
Marcelo Abreu
Marcus Schultz
Ary Serpa Neto
Raphael Cinotti (NC France)
Louis Blanch
Giacomo Bellani
Karim Asehnoune
Luigi Camporota
Christian Putensen
John Laffey

• International Point Prevalence Study of Intensive Care Unit Transfusion Practices –InPUT study

For the InPUT study, an international point prevalence study on transfusion practice on ICUs, we are looking for participating centres and national coordinators

Content InPUT study:

Study population: All patients ≥ 18 years, admitted in a pre-specified week.

Data collection:

  • Baseline characteristics
  • Daily until ICU discharge (with a maximum of 28 days)
  • For each transfusion event until ICU discharge (with a maximum of 28 days)
  • 28 day mortality

Primary outcome:  Number of red blood cell, platelet, and coagulation factors in relation to haemoglobin levels, platelet count and INR/PT.

Data entry: Online platform in REDCAP

Please read study protocol and the publication of the pilot feasibility study (https://www.sciencedirect.com/science/article/pii/S1246782019304379) for more information.

We provide authorship to all national coordinators and when allowed by the journal also for the local PIs. If not allowed we will mention them as collaboration partner which results in a Pubmed citation. Furthermore, participating centers are allowed to do additional studies on the data set. The steering committee will coordinate these additional research questions and additional analysis.

Tasks of national coordinators:

  • Recruit and coordinate with centers within your country
  • Ask for waiver or ethical approval at your IRB

Currently we have national coordinators in the following countries:

Austria Egypte Ireland Qatar Sri Lanka
Bangladesh France Italy Romania Sudan
Belgium Germany Libya Saudi Arabia Sweden
Brazil Greece Mexico Serbia Switzerland
Canada Hungary Netherlands Slovenia Turkey
Croatia India Pakistan South-Afrika United Arab Emirates
Czech Republic Iran Poland Spain United States
Ecuador Iraq

 

Contact persons:

Coordinating investigator: Sanne de Bruin

International principal investigator: Alexander Vlaar

If you have any questions and/or you are interested in participation, please contact us on inputstudy@amsterdamumc.nl

Documents:

• 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.

Chief Investigators
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

Survey of the SQUEEZE Study

Medical problem
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.

Objectives
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.

Outcome measures
Incidence of vasopressor use, and elucidation of risk factors
Postoperative organ dysfunction in patients receiving infused vasopressors.

Timeline
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.

Steering Committee
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.

Squeeze contact

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