Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients (PRoFLUID)

Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients (PRoFLUID)--an International Multicenter Observational Cohort Study

The goal of this woldwide observational study is to investigate various aspects of fluid and vasopressor therapy in critically ill invasively ventilated patients. The main questions it aims to answer are:

• What is the global current practice of fluid and vasopressor therapy?
• What are associations between this practice and clinical outcomes?

Participating intensive care units will gather detailed information about fluid and vasopressor therapy prescribed to participants. Participating intensive care units will also gather information about participant outcomes such as duration of invasive ventilation, length of stay and mortality

Study Overview

• Status: Completed
• Conditions: Critical Illness; Fluid Therapy; Invasive Ventilation; Vasopressor Therapy

Detailed Description

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.

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

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.

• Study Type: Observational
• Enrollment (Actual): 2508

Contacts and Locations

Study Locations

• Netherlands
  • North Holland
    • Amsterdam, North Holland, Netherlands
      • Amsterdam UMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Critically ill invasively ventilated patients that receive ventilation for at least 24 hours.

Description

Inclusion Criteria:

• Admitted to a participating intensive care unit;
• Receiving invasive ventilation; and
• Duration of ventilation > 24 hours.

Exclusion Criteria:

• Age < 16 years;
• Patients transferred under invasive ventilation from another intensive care unit.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of various aspects of fluid therapy	Including total volumes of types of fluids administered in the first three days after ICU admission and total volume of fluids infused in the first seven days of ICU admission	seven days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timing of start of continuous administration of vasopressors.	Timing of start of vasopressors from ICU admission in minutes per administration route (i.e. central versus peripheral)	seven days
Timing of start of administered diuretics.	Time between start of invasive ventilation and administration of diuretics in days	seven days
Bolus or continous infusion of diuretics		seven days
Cumulative fluid balances		seven days
Daily urine output		seven days
Incidence of atrial arrythmias		7 days
Incidence of acute respiratory distress syndrome		7 days
Incidence of renal replacement therapy		7 days
Incidence of need for renal replacement therapy at ICU discharge.		90 days
Typical ICU outcomes; e.g. duration of ventilation, lengths of stay in ICU and hospital and, mortality in the ICU and hospital		90 days
Types of vasopressors	The type (i.e. noradrenaline, vasopressin, adrenaline) of vasopressors that are prescribed	seven days
Types of diuretics	The type of diuretics that are prescribed	seven days
Duration of vasopressor therapy	In days	seven days
Concentration of types of vasopressors	The concentration (i.e. in µg/ml) of vasopressors that are prescribed per administration route	seven days
Duration of diuretic therapy	In days	seven days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-defined subgroup analysis in patients admitted with burns	All aforementioned outcomes in patients with burns	90 days
Pre-defined subgroup analysis in patients admitted with acute respiratory distress syndrome	All aforementioned outcomes in patients with acute respiratory distress syndrome	90 days
Pre-defined subgroup analysis in patients admitted with sepsis	All aforementioned outcomes in patients with sepsis	90 days

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Amsterdam UMC, location VUmc; University Hospital, Antwerp; Mahidol Oxford Tropical Medicine Research Unit
• Investigators: Principal Investigator: Pieter R. Tuinman, MD, Amsterdam Umc, Location Vumc; Principal Investigator: Frederique Paulus, Professor, Amsterdam UMC, location AMC; Principal Investigator: Marcus J. Schultz, Professor, Mahidol Oxford Tropical Medicine Research Unit

Publications and helpful links

General Publications

• PRoFLUID-Investigators. Practice of Fluid and Vasopressor Therapy in Critically Ill Invasively Ventilated Patients (PRoFLUID)-study protocol for an international multicenter observational cohort study. Ann Transl Med. 2024 Oct 20;12(5):92. doi: 10.21037/atm-23-1957. Epub 2024 Sep 12.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): September 23, 2025
• Study Completion (Actual): October 22, 2025

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Fluids; Resuscitation; Deresuscitation; Fluid Therapy; Vasopressor
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness
• Other Study ID Numbers: PRoFLUID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No