Amsterdam UMC
Amsterdam, North Holland, Netherlands
NCT Number: NCT05968066
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
Looking for future studies?
Notify Me16 year and older
All sexes
Observational
Amsterdam, North Holland, Netherlands
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: seven days
Timing of start of vasopressors from ICU admission in minutes per administration route (i.e. central versus peripheral)
Time frame: seven days
In days
Time frame: seven days
The type (i.e. noradrenaline, vasopressin, adrenaline) of vasopressors that are prescribed
Time frame: seven days
The concentration (i.e. in µg/ml) of vasopressors that are prescribed per administration route
Time frame: seven days
Time between start of invasive ventilation and administration of diuretics in days
Time frame: seven days
In days
Time frame: seven days
The type of diuretics that are prescribed
Time frame: seven days
Time frame: seven days
Time frame: seven days
Time frame: 7 days
Time frame: 7 days
Time frame: 7 days
Time frame: 90 days
Time frame: 90 days
Time frame: 90 days
All aforementioned outcomes in patients with burns
Time frame: 90 days
All aforementioned outcomes in patients with acute respiratory distress syndrome
Time frame: 90 days
All aforementioned outcomes in patients with sepsis
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Other
Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients (PRoFLUID)--an International Multicenter Observational Cohort Study
Acronym: PRoFLUID
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.
Published trials that share one or more normalized conditions with this study.
NCT07649694
Critical Illness, Disease Attributes
Samsun, Atakum, Turkey (Türkiye)
View Trial DetailsNCT04201704
Critical Illness, Disease Attributes
Buffalo, New York, United States
View Trial DetailsNCT05054452
Critical Illness, Disease Attributes
Le Kremlin-Bicêtre, France
View Trial DetailsNCT06206434
Dehydration, Fluid Therapy
Athens, Greece
View Trial Details