Clinical trial NCT05968066: Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients
Official title: Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients (PRoFLUID)--an International Multicenter Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fluid Therapy
Vasopressor Therapy
Critical Illness
Invasive Ventilation
Keywords: Fluid Therapy
Vasopressor
Resuscitation
Deresuscitation
Fluids
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Mahidol Oxford Tropical Medicine Research Unit
name: Amsterdam UMC, location VUmc
name: University Hospital, Antwerp
First posted: 2023-08-01
Enrollment: 2500
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill invasively ventilated patients that receive ventilation for at least 24 hours.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite of various aspects of fluid therapy
timeFrame: seven days
Secondary outcomes:
measure: Timing of start of continuous administration of vasopressors.
timeFrame: seven days
measure: Duration of vasopressor therapy
timeFrame: seven days
measure: Types of vasopressors
timeFrame: seven days
measure: Concentration of types of vasopressors
timeFrame: seven days
measure: Timing of start of administered diuretics.
timeFrame: seven days
measure: Duration of diuretic therapy
timeFrame: seven days
measure: Types of diuretics
timeFrame: seven days
measure: Bolus or continous infusion of diuretics
timeFrame: seven days
measure: Cumulative fluid balances
timeFrame: seven days
measure: Daily urine output
timeFrame: seven days
measure: Incidence of atrial arrythmias
timeFrame: 7 days
measure: Incidence of acute respiratory distress syndrome
timeFrame: 7 days
measure: Incidence of renal replacement therapy
timeFrame: 7 days
measure: Incidence of need for renal replacement therapy at ICU discharge.
timeFrame: 90 days
measure: Typical ICU outcomes; e.g. duration of ventilation, lengths of stay in ICU and hospital and, mortality in the ICU and hospital
timeFrame: 90 days
Other outcomes:
measure: Pre-defined subgroup analysis in patients admitted with burns
timeFrame: 90 days
measure: Pre-defined subgroup analysis in patients admitted with acute respiratory distress syndrome
timeFrame: 90 days
measure: Pre-defined subgroup analysis in patients admitted with sepsis
timeFrame: 90 days
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Pieter R. Tuinman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC, location AMC
name: Frederique Paulus, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Mahidol Oxford Tropical Medicine Research Unit
name: Marcus J. Schultz, Professor
role: PRINCIPAL_INVESTIGATOR
References: