NEWS
PRoFLUID registered on clinicaltrials.gov
PRoFLUID has been registered on clinicaltrials.gov
PRoFLUID pilot study concluded
A local pilot has been done for the PRoFLUID. The pilot included 45 invasively ventilated patients from the Amsterdam UMC during a 28 day inclusion period.
PRoFLUID has started!
On April 1st of 2024, the first 2 countries (with over 20 ICU's) have started the inclusion period for the PRoFLUID. Over 150 patients have been included already!
Currently recruiting centers and local coordinators
- We aim to gather an inclusive and diverse study team as well as provide opportunities for junior researchers
- Please contact us if you want to be involved in this project as a local coordinator or study center
Participation guidelines for centers
- Data entry per participant takes a median of 39 minutes
- Consecutive patients should be included over a 28-day period
- Centers are given the option to stop inclusion if 20 participants are included before the end of the study
Rationale
The worldwide practice of fluid and vasopressor therapy in critically ill invasively ventilated patients is uncertain. Indeed, it is unclear whether there is a difference in fluid and vasopressor therapy in these patients between Low– and Middle–income Countries (LMICs) and High–income Countries (HICs).
Objective
To determine various aspects of fluid and vasopressor therapy in critically ill invasively ventilated patients in LMICs and HICs.
Hypothesis
There is substantial worldwide variation in practice of fluid and vasopressor therapy in critically ill invasively ventilated patients.
Study design
International, multicenter, observational study in critically ill invasively ventilated patients; data are captured during a predefined period per geographic region or country.
Study population
Critically ill invasively ventilated patients.
Main study parameter/endpoint
The primary outcome is a composite of various aspects of fluid therapy, including total volumes of types of fluids administered in the first three days after start of invasive ventilation and total volume of fluids infused in the first seven days after start of invasive ventilation. Secondary outcomes include timing of start, type, and duration of continuous administration of vasopressors; timing of start, infusion time and types of administered diuretics; daily urine output and cumulative fluid balances; and typical ICU outcomes, like duration of ventilation, lengths of stay in ICU and hospital, and mortality in the ICU and hospital until day 90.
Nature and extent of the burden and risks associated with participation
Because of the observational design of the study using routinely collected data, there is no additional burden for the patient. Collection of data from ICU charts or electronic medical records systems is of no risk to the patients.
Feasibility and workload
The study was piloted in the Amsterdam UMC. Data entry took approximately 45 minutes per participant. Missing data was minimal.
Documents
The study protocol is available here
Study team
Steering Comittee
Dr. C. Barbas (Brazil)
Drs. S.G. Blok (The Netherlands).
Prof. M. Chew (Sweden).
Prof. A. Dondorp (Thailand).
Prof. A. Dubin (Argentina).
Dr. H.J. de Grooth (The Netherlands).
Dr. N. Hammond (Australia).
Prof. F. van Haren (Australia).
Prof. A. Kwizera (Uganda).
Prof. M. Malbrain (Belgium).
Prof. X. Monnet (France).
Prof. S. Myatra (India).
Prof. F. Paulus (The Netherlands).
Dr. L. Pisani (Italy).
Prof. L. Rose (United Kingdom).
Prof. M.J. Schultz (The Netherlands).
Prof. A. Serpa Neto (Australia).
Dr. Z. Shi (China).
Dr. J. Silversides (United Kingdom).
Dr. N. van Regenmortel (Belgium).
Dr. P.R. Tuinman (The Netherlands).
Prof. S. Tripathy (India)
National coordinators
Recruitment for national coordinators is currently closed
Africa
- Dr. M. Sultan - Ethiopia
- Dr. C. Sendagire - Uganda
- Dr. David Thomson - South-Africa
- Prof. W. Siika - Kenya
Asia:
- Dr. S.K. Manggala - Indonesia
- Prof. S. Myatra & Prof. S. Tripathy - India
- Dr. Z. Shi - China
- Dr. H. Koyama - Japan
- Prof. A. Ghose - Bangladesh
- Dr. M. Shamal - Afghanistan
- Dr G. Shrestha - Nepal
- Dr. S. Vengadasalam - Sri-Lanka
- Prof. G. Lundeg - Mongolia
- Dr. L. Ferlicolak - Türkiye
- Dr. M. Shamal - Afghanistan
Europe:
- S.G. Blok - The Netherlands
- Dr. F. Duska - Czech Republic
- Prof. R. Ferrer - Spain
- Prof L. Vetrugni - Italy
- Dr. K. Vaporidi - Greece
- Dr. M. Tavares - Portugal
- Dr. N. Hammer - Denmark
- Prof. X. Monnet & Mathieu Jozwiak - France
- Prof. M. Chew - Sweden
- Dr. J. Narum - Norway
- Prof. Dabrowski - Poland
- Dr. M. Bernardi - Austria
- Prof. G. Curley - Ireland
- Dr. A. Šribar - Croatia
- Prof. C. Pfortmueller - Switzerland
- Dr. N. van Regenmortel - Belgium
- Dr. C. Balan & Prof. Serban-Ion Bubenek-Turconi - Romania
- Dr. H. Groesdonk - Germany
- Dr. T. Kareli - Georgia
- Dr. M. Bernardi - Austria
- Prof. L Rose & Dr. J. Silversides - UK
Middle-East:
- Dr. A. Taha - United Arab Emirates
- Dr. M. Monajati - Iran
- Prof. Lou'i Al-Husinat - Jordan
- Dr. T. Hay - Egypt
North America:
- Dr. A. Perez - Mexico
- Dr. A. Goffi - Canada
Oceania:
- Prof. N. Hammond & Prof. F.M.P. van Haren - Australia
- Prof. N. Hammond & Prof. F.M.P. van Haren - New Zealand
South America:
- Prof. Martin Angulo & Dr. J. Hurtado - Uruguay
- Dr. B. Lattanzio - Argentina
- Dr. E.D. Valenzuela - Chile
- Dr. N. Soderberg - Brazil
- Dr. A. Caballero - Colombia
- Dr. B. Panka - Surinam
- Dr R. Recalde - Paraguay
eCRF
The eCRF is built in Castor EDC, a program that can be reached from everywhere via the internet.
Trial registration
Registration of the PRoFLUID study at clinicaltrials.gov.
Documents
Contact
Questions or interested in participating in PRoFLUID?
Please contact us.
