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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
9/05/2024

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.
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).
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.
Timepoint [2] 0 0
28 days
Secondary outcome [3] 0 0
Number of days with fluid accumulation during the ICU stay.
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).
Timepoint [4] 0 0
28 days
Secondary outcome [5] 0 0
Days alive without use of life-support within 28 days from ICU admission.
Timepoint [5] 0 0
28 days
Secondary outcome [6] 0 0
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.
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
1/08/2025
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
Switzerland
State/province [17] 0 0
Bern
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Cardiff

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

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT06258616
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 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
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06258616