Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients

Status Not yet recruiting

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05968066
Study type	Observational
Source	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact	Siebe G. Blok, MD
Phone	020 566 9111
Email	siebeblok@gmail.com
Status	Not yet recruiting
Phase
Start date	December 2023
Completion date	July 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients — PRoFLUID

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms