Fluid AccumulationFLUID-ICUNCT06258616
Fluid Administration and Fluid Accumulation in the Intensive Care Unit
An observational study of Fluid Accumulation and Fluid Therapy, run by Nordsjaellands Hospital at 21 sites in 11 countries.
Trial summary
The goal of this international inception cohort study is to describe fluid administration during admittance to the intensive care unit (ICU), and provide contemporary epidemiological data on fluid accumulation, risk factors, management and outcome in critically ill adult patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Accumulation, Fluid Therapy, Fluid Overload
- How many people
- 1,755 participants
- Where
- 21 sitesin 11 countries
- Study dates
- 1 Apr 2024to 1 Oct 2025
- How long will I take part?
- 90 Days
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients admitted to the participating ICUs during the 14-inception period.
Who may be able to join
- Acute admission to the ICU during the 14-day inception period.
- Adults (≥ 18 years).
Who cannot join
- Patients previously included in the FLUID-ICU study.
- Patients with major burns (≥ 10% of body surface)
Trial locations and contacts
21 sites in 11 countries.
21 sites in 11 countries
Denmark11 sites
Department of Intensive Care, Sygehus Sønderjylland Aabenraa
Aabenraa
Departmen of Intensive Care
Aalborg, 9000
Department of Intensive Care, University hospital Aarhus
Aarhus
Department of Intensive Care, Rigshospitalet 4131
Copenhagen, 2100
Department of Intensive Care, Bispebjerg
Copenhagen, 7100
Department of Intensive Care, Herlev Hospital
Herlev, 2730
Department of Intensive Care, Regionshospital Gødstrup
Herning, 7400
Deparment of Intensive care, Nordsjællands hospital
Hillerød, Hillerød, 3400
Department of Intensive Care, Zealand University hospital
Køge, 4600
Department of Intensive Care, Regionshospitalet Randers
Randers, 8930
Department of Intensive Care, University Hospital Zealand, Roskilde
Roskilde
Finland1 site
Department of Intensive Care, Tampere University Hospital
Tampere, 33520
Iceland1 site
Department of Intensive Care, Landspitali National University Hospital of Iceland
Reykjavik
India1 site
Department of Anaesthesiology, Critical Care and Pain Tata Memorial Hospital, Mumbai.
Mumbai
Lithuania1 site
Department of Anaesthesia and Critical Care Vilnuis University Hospital Santariskiu Cinics, Vilnuis
Vilnius
New Zealand1 site
Department of Intensive Care Wellington Hospital (CCDHB), Newton, Wellington
Wellington
Norway1 site
Department of Intensive Care, Stavanger University Hospital
Stavanger, 4068
United Kingdom1 site
General Adult Intensive Care Unit, Critical Care Directorate University Hospital of Wales, Cardiff
Cardiff
About this study
Official title: Fluid Administration and Fluid Accumulation in the Intensive Care Unit (FLUID-ICU) - an International Inception Cohort Study
The goal of this international inception cohort study is to describe fluid administration during admittance to the intensive care unit (ICU), and provide contemporary epidemiological data on fluid accumulation, risk factors, management and outcome in critically ill adult patients.
Read the detailed description
Background: Fluid accumulation is associated with adverse outcome in ICU patients, however, assessment of fluid status is often difficult and no established definition and consistent detection method exists. Former research has primarily focused on the use of resuscitation fluid, but a substantial amount of fluid is administered throughout the entire ICU stay and this fluid may be a clinically relevant source of fluid accumulation.
Objectives: To describe fluid administration practices during the entire ICU stay, and provide contemporary epidemiological data on fluid accumulation, fluid removal, risk factors and association with patient outcomes from a worldwide perspective.
Study design: International inception cohort study. Patients will be included during a 14-day inception period to be chosen by each participating site.
Population: Critically ill adult patients (≥ 18 years) with acute admission to the ICU.
Intervention: None. Only routinely available data will be collected.
Study duration: Patients are followed daily until ICU discharge or death for a maximum of 28 days. Follow-up is performed 90 days after ICU admission.
- Conditions
- Fluid Accumulation, Fluid Therapy, Fluid Overload
- Keywords
- Fluid Overload, Fluid Accumulation, Fluid Administration
- Medical subject headings
- Edema
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with fluid accumulation.
The presence of fluid accumulation is defined as the best clinical estimate made by the study investigators, using medical records and the treating team's clinical assessment, and one or more of the following parameters: Cumulative fluid balance, daily fluid balance, changes in body weight, and/or clinical signs of fluid accumulation (e.g. peripheral oedema, pulmonary oedema, congestion on chest X-ray or lung ultrasound).
Measured: From ICU admission to discharge (with a maximum of 28 days).
Secondary outcomes (7)
Number of patients with fluid accumulation upon ICU admission (baseline).
Defined as the number of patients with fluid accumulation upon ICU admission or equal to the time of ICU assessed by study investigators using cumulative fluid balance, daily fluid balance, changes in body weight and clinical signs of fluid accumulation.
Measured: On the first day of ICU admission (Day 1).
Number of patients developing fluid accumulation during the ICU stay.
Defined as the number of patients developing fluid accumulation during ICU stay (one or more episodes) but no pre-existing fluid accumulation upon ICU admission (baseline form).
Measured: 28 days
Number of days with fluid accumulation during the ICU stay.
Defined as the median number of days with fluid accumulation in patient with fluid accumulation at baseline and/or during ICU stay at day 28 after ICU admission.
Measured: 28 days
Number of patients being treated with 'active fluid removal' (use of diuretics, or renal replacement therapy).
Defined as patients that receive treatment with any type of diuretics or renal replacement therapy.
Measured: 28 days
Days alive without use of life-support within 28 days from ICU admission.
Days alive without use of life-support (continuous infusion of vasopressors/inotropes, invasive mechanical ventilation or renal replacement therapy).
Measured: 28 days
Days alive and out of hospital within 90 days from ICU admission.
Total number of days alive and out of hospital within 90 days from ICU admission,
Measured: 90 days
Mortality within 90 days from ICU admission.
Death from all causes.
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 posted14 Feb 2024
- Study start1 Apr 2024
- Primary completion31 May 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid AccumulationStudies of the same condition, open and under way.
- 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
- 1,755 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258616
- Sponsor's protocol ID
- FLUID-ICU
- Acronym
- FLUID-ICU
- Status last verified
- Aug 2026
- First submitted
- 22 Jan 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Administration and Fluid Accumulation in the Intensive Care Unit (FLUID-ICU) - an International Inception Cohort Study
- ClinicalTrials.gov ID
- NCT06258616
- Acronym / sponsor ID
- FLUID-ICU / FLUID-ICU
- Conditions
- Fluid Accumulation, Fluid Therapy, Fluid Overload
- Keywords
- Fluid Overload, Fluid Accumulation, Fluid Administration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,755 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen, Copenhagen University Hospital, Rigshospitalet
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 14 Feb 2024 (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 international inception cohort study is to describe fluid administration during admittance to the intensive care unit (ICU), and provide contemporary epidemiological data on fluid accumulation, risk factors, management and outcome in critically ill adult patients.
Detailed description
Background: Fluid accumulation is associated with adverse outcome in ICU patients, however, assessment of fluid status is often difficult and no established definition and consistent detection method exists. Former research has primarily focused on the use of resuscitation fluid, but a substantial amount of fluid is administered throughout the entire ICU stay and this fluid may be a clinically relevant source of fluid accumulation.
Objectives: To describe fluid administration practices during the entire ICU stay, and provide contemporary epidemiological data on fluid accumulation, fluid removal, risk factors and association with patient outcomes from a worldwide perspective.
Study design: International inception cohort study. Patients will be included during a 14-day inception period to be chosen by each participating site.
Population: Critically ill adult patients (≥ 18 years) with acute admission to the ICU.
Intervention: None. Only routinely available data will be collected.
Study duration: Patients are followed daily until ICU discharge or death for a maximum of 28 days. Follow-up is performed 90 days after ICU admission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the participating ICUs during the 14-inception period.
Key inclusion criteria (2 listed)
- Acute admission to the ICU during the 14-day inception period.
- Adults (≥ 18 years).
Key exclusion criteria (2 listed)
- Patients previously included in the FLUID-ICU study.
- Patients with major burns (≥ 10% of body surface)
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
The number of patients with fluid accumulation.
Time frame: From ICU admission to discharge (with a maximum of 28 days).
The presence of fluid accumulation is defined as the best clinical estimate made by the study investigators, using medical records and the treating team's clinical assessment, and one or more of the following parameters: Cumulative fluid balance, daily fluid balance, changes in body weight, and/or clinical signs of fluid accumulation (e.g. peripheral oedema, pulmonary oedema, congestion on chest X-ray or lung ultrasound).
7 secondary outcomes
Number of patients with fluid accumulation upon ICU admission (baseline).
Time frame: On the first day of ICU admission (Day 1).
Number of patients developing fluid accumulation during the ICU stay.
Time frame: 28 days
Number of days with fluid accumulation during the ICU stay.
Time frame: 28 days
Number of patients being treated with 'active fluid removal' (use of diuretics, or renal replacement therapy).
Time frame: 28 days
Days alive without use of life-support within 28 days from ICU admission.
Time frame: 28 days
Days alive and out of hospital within 90 days from ICU admission.
Time frame: 90 days
Mortality within 90 days from ICU admission.
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 10 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fluid Accumulation and Fluid Therapy, run by Nordsjaellands Hospital at 21 sites in 11 countries.
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 2 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 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Denmark, Finland, Iceland, India, Lithuania and 6 more countries. 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?
The number of patients with fluid accumulation. (time frame: From ICU admission to discharge (with a maximum of 28 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026.