Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients

NCT05968066 | Completed

• 1 other identifier: PRoFLUID
• Study Type: observational
• Target: 2,508
• Locations: 1 country
• Sites: 1

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

Conditions

Fluid Therapy; Vasopressor Therapy; Critical Illness; Invasive Ventilation

Keywords

Fluid Therapy; Vasopressor; Resuscitation; Deresuscitation; Fluids

Outcome Measures

Primary Outcomes (1)

• Composite of various aspects of fluid therapy

  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

  seven days

Secondary Outcomes (15)

• Timing of start of continuous administration of vasopressors.

  seven days

• Duration of vasopressor therapy

  seven days

• Types of vasopressors

  seven days

• Concentration of types of vasopressors

  seven days

• Timing of start of administered diuretics.

  seven days

Other Outcomes (3)

• Pre-defined subgroup analysis in patients admitted with burns

  90 days

• Pre-defined subgroup analysis in patients admitted with acute respiratory distress syndrome

  90 days

• Pre-defined subgroup analysis in patients admitted with sepsis

  90 days

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Critically ill invasively ventilated patients that receive ventilation for at least 24 hours.

You may qualify if:

• Admitted to a participating intensive care unit;
• Receiving invasive ventilation; and
• Duration of ventilation \> 24 hours.

You may not qualify if:

• Age \< 16 years;
• Patients transferred under invasive ventilation from another intensive care unit.

Sponsors & Collaborators

• Mahidol Oxford Tropical Medicine Research Unit: collaborator
• Amsterdam UMC, location VUmc: collaborator
• University Hospital, Antwerp: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 39507456 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pieter R. Tuinman, MD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

• Frederique Paulus, Professor

  Amsterdam UMC, location AMC

  PRINCIPAL INVESTIGATOR

• Marcus J. Schultz, Professor

  Mahidol Oxford Tropical Medicine Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: August 1, 2023
• Study Start: December 1, 2023
• Primary Completion: September 23, 2025
• Study Completion: October 22, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-09

Locations

NL (1)