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Completed

NCT Number: NCT05968066

Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients

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

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC

Amsterdam, North Holland, Netherlands

About this 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.

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Composite of various aspects of fluid therapy

    Time frame: seven days

    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

Secondary outcomes

  1. Timing of start of continuous administration of vasopressors.

    Time frame: seven days

    Timing of start of vasopressors from ICU admission in minutes per administration route (i.e. central versus peripheral)

  2. Duration of vasopressor therapy

    Time frame: seven days

    In days

  3. Types of vasopressors

    Time frame: seven days

    The type (i.e. noradrenaline, vasopressin, adrenaline) of vasopressors that are prescribed

  4. Concentration of types of vasopressors

    Time frame: seven days

    The concentration (i.e. in µg/ml) of vasopressors that are prescribed per administration route

  5. Timing of start of administered diuretics.

    Time frame: seven days

    Time between start of invasive ventilation and administration of diuretics in days

  6. Duration of diuretic therapy

    Time frame: seven days

    In days

  7. Types of diuretics

    Time frame: seven days

    The type of diuretics that are prescribed

  8. Bolus or continous infusion of diuretics

    Time frame: seven days

  9. Cumulative fluid balances

    Time frame: seven days

  10. Daily urine output

    Time frame: seven days

  11. Incidence of atrial arrythmias

    Time frame: 7 days

  12. Incidence of acute respiratory distress syndrome

    Time frame: 7 days

  13. Incidence of renal replacement therapy

    Time frame: 7 days

  14. Incidence of need for renal replacement therapy at ICU discharge.

    Time frame: 90 days

  15. Typical ICU outcomes; e.g. duration of ventilation, lengths of stay in ICU and hospital and, mortality in the ICU and hospital

    Time frame: 90 days

Other outcomes

  1. Pre-defined subgroup analysis in patients admitted with burns

    Time frame: 90 days

    All aforementioned outcomes in patients with burns

  2. Pre-defined subgroup analysis in patients admitted with acute respiratory distress syndrome

    Time frame: 90 days

    All aforementioned outcomes in patients with acute respiratory distress syndrome

  3. Pre-defined subgroup analysis in patients admitted with sepsis

    Time frame: 90 days

    All aforementioned outcomes in patients with sepsis

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • Amsterdam UMC, location VUmc
  • Mahidol Oxford Tropical Medicine Research Unit
  • University Hospital, Antwerp

Registry information

Official study title

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

Acronym: PRoFLUID

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 1, 2023
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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