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Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05968066
Acronym
PRoFLUID
Enrollment
2508
Registered
2023-08-01
Start date
2023-12-01
Completion date
2025-10-22
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Fluid Therapy, Invasive Ventilation, Vasopressor Therapy

Keywords

Fluid Therapy, Vasopressor, Resuscitation, Deresuscitation, Fluids

Brief summary

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

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.

Interventions

None listed

Sponsors

Mahidol Oxford Tropical Medicine Research Unit
CollaboratorOTHER
Amsterdam UMC, location VUmc
CollaboratorOTHER
University Hospital, Antwerp
CollaboratorOTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Composite of various aspects of fluid therapyseven daysIncluding 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

Secondary

MeasureTime frameDescription
Typical ICU outcomes; e.g. duration of ventilation, lengths of stay in ICU and hospital and, mortality in the ICU and hospital90 days
Incidence of acute respiratory distress syndrome7 days
Incidence of renal replacement therapy7 days
Incidence of need for renal replacement therapy at ICU discharge.90 days
Timing of start of continuous administration of vasopressors.seven daysTiming of start of vasopressors from ICU admission in minutes per administration route (i.e. central versus peripheral)
Duration of vasopressor therapyseven daysIn days
Types of vasopressorsseven daysThe type (i.e. noradrenaline, vasopressin, adrenaline) of vasopressors that are prescribed
Concentration of types of vasopressorsseven daysThe concentration (i.e. in µg/ml) of vasopressors that are prescribed per administration route
Timing of start of administered diuretics.seven daysTime between start of invasive ventilation and administration of diuretics in days
Duration of diuretic therapyseven daysIn days
Types of diureticsseven daysThe type of diuretics that are prescribed
Bolus or continous infusion of diureticsseven days
Cumulative fluid balancesseven days
Daily urine outputseven days
Incidence of atrial arrythmias7 days

Other

MeasureTime frameDescription
Pre-defined subgroup analysis in patients admitted with acute respiratory distress syndrome90 daysAll aforementioned outcomes in patients with acute respiratory distress syndrome
Pre-defined subgroup analysis in patients admitted with sepsis90 daysAll aforementioned outcomes in patients with sepsis
Pre-defined subgroup analysis in patients admitted with burns90 daysAll aforementioned outcomes in patients with burns

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026