Fluid TherapyPRoFLUIDNCT05968066
Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients
An observational study of Fluid Therapy and Vasopressor Therapy, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Fluid Therapy, Vasopressor Therapy, Critical Illness
- How many people
- 2,508 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2023to 22 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Critically ill invasively ventilated patients that receive ventilation for at least 24 hours.
Who may be able to join
- Admitted to a participating intensive care unit;
- Receiving invasive ventilation; and
- Duration of ventilation > 24 hours.
Who cannot join
- Age < 16 years;
- Patients transferred under invasive ventilation from another intensive care unit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients (PRoFLUID)--an International Multicenter Observational Cohort Study
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
Read the 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.
- Keywords
- Fluid Therapy, Vasopressor, Resuscitation, Deresuscitation, Fluids
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: seven days
Secondary outcomes (15)
Timing of start of continuous administration of vasopressors.
Timing of start of vasopressors from ICU admission in minutes per administration route (i.e. central versus peripheral)
Measured: seven days
Duration of vasopressor therapy
In days
Measured: seven days
Types of vasopressors
The type (i.e. noradrenaline, vasopressin, adrenaline) of vasopressors that are prescribed
Measured: seven days
Concentration of types of vasopressors
The concentration (i.e. in µg/ml) of vasopressors that are prescribed per administration route
Measured: seven days
Timing of start of administered diuretics.
Time between start of invasive ventilation and administration of diuretics in days
Measured: seven days
Duration of diuretic therapy
In days
Measured: seven days
Types of diuretics
The type of diuretics that are prescribed
Measured: seven days
Bolus or continous infusion of diuretics
Measured: seven days
Cumulative fluid balances
Measured: seven days
Daily urine output
Measured: seven days
Incidence of atrial arrythmias
Measured: 7 days
Incidence of acute respiratory distress syndrome
Measured: 7 days
Incidence of renal replacement therapy
Measured: 7 days
Incidence of need for renal replacement therapy at ICU discharge.
Measured: 90 days
Typical ICU outcomes; e.g. duration of ventilation, lengths of stay in ICU and hospital and, mortality in the ICU and hospital
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Dec 2023
- Primary completion23 Sep 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fluid TherapyStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,508 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit, Amsterdam UMC, location VUmc, University Hospital, Antwerp
- Responsible party
- Principal investigator, Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Pieter R. Tuinman, MD, Principal investigator, Amsterdam UMC, location VUmcFrederique Paulus, Professor, Principal investigator, Amsterdam UMC, location AMCMarcus J. Schultz, Professor, Principal investigator, Mahidol Oxford Tropical Medicine Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968066
- Sponsor's protocol ID
- PRoFLUID
- Acronym
- PRoFLUID
- Status last verified
- Sep 2025
- First submitted
- 10 Jul 2023
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39507456
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice of Fluid Therapy in Critically Ill Invasively Ventilated Patients (PRoFLUID)--an International Multicenter Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05968066
- Acronym / sponsor ID
- PRoFLUID / PRoFLUID
- Keywords
- Fluid Therapy, Vasopressor, Resuscitation, Deresuscitation, Fluids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,508 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit, Amsterdam UMC, location VUmc, University Hospital, Antwerp
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Critically ill invasively ventilated patients that receive ventilation for at least 24 hours.
Key inclusion criteria (3 listed)
- Admitted to a participating intensive care unit;
- Receiving invasive ventilation; and
- Duration of ventilation > 24 hours.
Key exclusion criteria (2 listed)
- Age < 16 years;
- Patients transferred under invasive ventilation from another intensive care unit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite of various aspects of fluid therapy
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
15 secondary outcomes
Timing of start of continuous administration of vasopressors.
Time frame: seven days
Duration of vasopressor therapy
Time frame: seven days
Types of vasopressors
Time frame: seven days
Concentration of types of vasopressors
Time frame: seven days
Timing of start of administered diuretics.
Time frame: seven days
Duration of diuretic therapy
Time frame: seven days
Types of diuretics
Time frame: seven days
Bolus or continous infusion of diuretics
Time frame: seven days
Cumulative fluid balances
Time frame: seven days
Daily urine output
Time frame: seven days
Incidence of atrial arrythmias
Time frame: 7 days
Incidence of acute respiratory distress syndrome
Time frame: 7 days
Incidence of renal replacement therapy
Time frame: 7 days
Incidence of need for renal replacement therapy at ICU discharge.
Time frame: 90 days
Typical ICU outcomes; e.g. duration of ventilation, lengths of stay in ICU and hospital and, mortality in the ICU and hospital
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Derived from this study: PubMed 39507456PRoFLUID-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pieter R. Tuinman, MD principal investigator
Amsterdam UMC, location VUmc
Frederique Paulus, Professor principal investigator
Amsterdam UMC, location AMC
Marcus J. Schultz, Professor principal investigator
Mahidol Oxford Tropical Medicine Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Therapy and Vasopressor Therapy, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of various aspects of fluid therapy (time frame: seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05968066, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.