Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients
NCT ID: NCT05968066
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2508 participants
OBSERVATIONAL
2023-12-01
2025-10-22
Brief Summary
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* 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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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Receiving invasive ventilation; and
* Duration of ventilation \> 24 hours.
Exclusion Criteria
* Patients transferred under invasive ventilation from another intensive care unit.
16 Years
ALL
No
Sponsors
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Mahidol Oxford Tropical Medicine Research Unit
OTHER
Amsterdam UMC, location VUmc
OTHER
University Hospital, Antwerp
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Prof. Dr. Marcus J. Schultz
Prof. Dr.
Principal Investigators
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Pieter R. Tuinman, MD
Role: PRINCIPAL_INVESTIGATOR
Amsterdam UMC, location VUmc
Frederique Paulus, Professor
Role: PRINCIPAL_INVESTIGATOR
Amsterdam UMC, location AMC
Marcus J. Schultz, Professor
Role: PRINCIPAL_INVESTIGATOR
Mahidol Oxford Tropical Medicine Research Unit
Locations
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Amsterdam UMC
Amsterdam, North Holland, Netherlands
Countries
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References
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PRoFLUID-Investigators. Practice of Fluid and Vasopressor Therapy in Critically Ill Invasively Ventilated Patients (PRoFLUID)-study protocol for an international multicenter observational cohort study. Ann Transl Med. 2024 Oct 20;12(5):92. doi: 10.21037/atm-23-1957. Epub 2024 Sep 12.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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PRoFLUID
Identifier Type: -
Identifier Source: org_study_id
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