Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-27 @ 5:13 AM
Study NCT ID:
NCT05968066
Status:
COMPLETED
Last Update Posted:
2025-12-03
First Post:
2023-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Organization:
Study Overview
Official Title:
Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients (PRoFLUID)--an International Multicenter Observational Cohort Study
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRoFLUID
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
* 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: