Welcome to the PRoFLUID study page

Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients (PRoFLUID) is a global multicenter observational study. On this webpage you can find study information for participating researchers and interested parties.

NEWS

8 augustus 2023

PRoFLUID registered on clinicaltrials.gov

PRoFLUID has been registered on clinicaltrials.gov

8 augustus 2023

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.

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

  1. Data entry per participant takes 45-60 minutes
  2. Consecutive patients should be included over a 28-day period
  3. 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

Study protocol is drafted and will soon be publicly available.

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

We are currently recruiting national coordinators. This list is subject to change.

Africa

  • Dr. M. Sultan - Ethiopia

Asia:

  • Dr. S.K. Manggala - Indonesia
  • Prof. S. Myatra - India
  • Prof. S. Tripathy - India
  • Dr. Z. Shi - China
  • Dr. H. Koyama - Japan
  • Prof. A. Ghose - Bangladesh
  • Dr. M. Shamal - Afghanistan
  • Prof. M. Basri Mat Nor - Malaysia
  • Dr G. Shrestha - Nepal
  • Dr. S. Vengadasalam - Sri-Lanka
  • Dr Y. Lam Minh - Vietnam

Europe:

  • Dr. C. Balan - Romania
  • S.G. Blok - The Netherlands
  • Dr. F. Duska - Czech Republic
  • Prof. R. Ferrer - Spain
  • Prof L. Vetrugni - Italy
  • Dr. K. Vaporidi - Greece
  • Dr. J. Gouveia - Portugal
  • Prof. J. Hästbacka - Finland
  • Prof. X. Monnet - France
  • Prof. M. Chew - Sweden
  • Dr. S. Pischke - 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

Middle-East:

  • Dr. P. Nasa - United Arab Emirates

North America:

  • Dr. A. Perez - Mexico

Oceania:

  • Prof. N. Hammond - Australia
  • Prof. F.M.P. van Haren - Australia

South America:

  • Prof. Martin Angulo - Uruguay
  • Dr. B. Lattanzio - Argentina
  • Dr. E.D. Valenzuela - Chile
  • Dr. N. Soderberg - Brazil
  • Dr. A. Caballero - Colombia

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.

Formulier Afbeelding

Contact us to participate