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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
Trial website
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
claramolinmolin@gmail.com
Contact person for scientific queries

No information has been provided regarding IPD availability


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