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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06258616




Registration number
NCT06258616
Ethics application status
Date submitted
22/01/2024
Date registered
14/02/2024
Date last updated
25/03/2025

Titles & IDs
Public title
Fluid Administration and Fluid Accumulation in the Intensive Care Unit
Scientific title
Fluid Administration and Fluid Accumulation in the Intensive Care Unit (FLUID-ICU) - an International Inception Cohort Study
Secondary ID [1] 0 0
FLUID-ICU
Universal Trial Number (UTN)
Trial acronym
FLUID-ICU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fluid Accumulation 0 0
Fluid Therapy 0 0
Fluid Overload 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The number of patients with fluid accumulation.
Assessment method [1] 0 0
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).
Timepoint [1] 0 0
From ICU admission to discharge (with a maximum of 28 days).
Secondary outcome [1] 0 0
Number of patients with fluid accumulation upon ICU admission (baseline).
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
On the first day of ICU admission (Day 1).
Secondary outcome [2] 0 0
Number of patients developing fluid accumulation during the ICU stay.
Assessment method [2] 0 0
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).
Timepoint [2] 0 0
28 days
Secondary outcome [3] 0 0
Number of days with fluid accumulation during the ICU stay.
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
28 days
Secondary outcome [4] 0 0
Number of patients being treated with 'active fluid removal' (use of diuretics, or renal replacement therapy).
Assessment method [4] 0 0
Defined as patients that receive treatment with any type of diuretics or renal replacement therapy.
Timepoint [4] 0 0
28 days
Secondary outcome [5] 0 0
Days alive without use of life-support within 28 days from ICU admission.
Assessment method [5] 0 0
Days alive without use of life-support (continuous infusion of vasopressors/inotropes, invasive mechanical ventilation or renal replacement therapy).
Timepoint [5] 0 0
28 days
Secondary outcome [6] 0 0
Days alive and out of hospital within 90 days from ICU admission.
Assessment method [6] 0 0
Total number of days alive and out of hospital within 90 days from ICU admission,
Timepoint [6] 0 0
90 days
Secondary outcome [7] 0 0
Mortality within 90 days from ICU admission.
Assessment method [7] 0 0
Death from all causes.
Timepoint [7] 0 0
90 days

Eligibility
Key inclusion criteria
* Acute admission to the ICU during the 14-day inception period.
* Adults (= 18 years).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients previously included in the FLUID-ICU study.
* Patients with major burns (= 10% of body surface)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Aabenraa
Country [2] 0 0
Denmark
State/province [2] 0 0
Aalborg
Country [3] 0 0
Denmark
State/province [3] 0 0
Aarhus
Country [4] 0 0
Denmark
State/province [4] 0 0
Copenhagen
Country [5] 0 0
Denmark
State/province [5] 0 0
Herlev
Country [6] 0 0
Denmark
State/province [6] 0 0
Herning
Country [7] 0 0
Denmark
State/province [7] 0 0
Hillerød
Country [8] 0 0
Denmark
State/province [8] 0 0
Køge
Country [9] 0 0
Denmark
State/province [9] 0 0
Randers
Country [10] 0 0
Denmark
State/province [10] 0 0
Roskilde
Country [11] 0 0
Finland
State/province [11] 0 0
Tampere
Country [12] 0 0
Iceland
State/province [12] 0 0
Reykjavík
Country [13] 0 0
India
State/province [13] 0 0
Mumbai
Country [14] 0 0
Lithuania
State/province [14] 0 0
Vilnius
Country [15] 0 0
New Zealand
State/province [15] 0 0
Wellington
Country [16] 0 0
Norway
State/province [16] 0 0
Stavanger
Country [17] 0 0
Spain
State/province [17] 0 0
Barcelona
Country [18] 0 0
Sweden
State/province [18] 0 0
Helsingborg
Country [19] 0 0
Switzerland
State/province [19] 0 0
Bern
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Cardiff

Funding & Sponsors
Primary sponsor type
Other
Name
Nordsjaellands Hospital
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Copenhagen
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Rigshospitalet, Denmark
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clara Molin, MD, PhD student
Address 0 0
Country 0 0
Phone 0 0
+4528683965
Email 0 0
claramolinmolin@gmail.com
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06258616