Clinical trial NCT06258616: Fluid Administration and Fluid Accumulation in the Intensive Care Unit
Official title: Fluid Administration and Fluid Accumulation in the Intensive Care Unit (FLUID-ICU) - an International Inception Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fluid Accumulation
Fluid Therapy
Fluid Overload
Keywords: Fluid Overload
Fluid Accumulation
Fluid Administration
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Rigshospitalet, Denmark
First posted: 2024-02-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to the participating ICUs during the 14-inception period.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Acute admission to the ICU during the 14-day inception period.
* Adults (≥ 18 years).

Exclusion Criteria:

* Patients previously included in the FLUID-ICU study.
* Patients with major burns (≥ 10% of body surface)

Primary outcomes:
measure: The number of patients with fluid accumulation.
timeFrame: From ICU admission to discharge (with a maximum of 28 days).
Secondary outcomes:
measure: Number of patients with fluid accumulation upon ICU admission (baseline).
timeFrame: On the first day of ICU admission (Day 1).
measure: Number of patients developing fluid accumulation during the ICU stay.
timeFrame: 28 days
measure: Number of days with fluid accumulation during the ICU stay.
timeFrame: 28 days
measure: Number of patients being treated with 'active fluid removal' (use of diuretics, or renal replacement therapy).
timeFrame: 28 days
measure: Days alive without use of life-support within 28 days from ICU admission.
timeFrame: 28 days
measure: Days alive and out of hospital within 90 days from ICU admission.
timeFrame: 90 days
measure: Mortality within 90 days from ICU admission.
timeFrame: 90 days
Other outcomes:
measure: The volume (mL) of fluid administered day 1-7 and after 28 days in the following categories: Resuscitation fluid, maintenance-replacement fluid, fluid creep, nutrition, blood products.
timeFrame: Day 1-7 and after 28 days.
measure: Fluid balance (mL) during ICU stay on day 1-7 and 28 days after ICU admission
timeFrame: Day 1-7 and after 28 days
measure: Cumulative fluid balance (mL) day 1-7 and 28 days after ICU admission
timeFrame: Day 1-7 and after 28 days.
Locations:
city: Aabenraa
country: Denmark
facility: Department of Intensive Care, Sygehus Sønderjylland Aabenraa
city: Aalborg
country: Denmark
facility: Departmen of Intensive Care
city: Aarhus
country: Denmark
facility: Department of Intensive Care, University hospital Aarhus
city: Copenhagen
country: Denmark
facility: Department of Intensive Care, Rigshospitalet 4131
city: Copenhagen
country: Denmark
facility: Department of Intensive Care, Bispebjerg
city: Herlev
country: Denmark
facility: Department of Intensive Care, Herlev Hospital
city: Herning
country: Denmark
facility: Department of Intensive Care, Regionshospital Gødstrup
city: Hillerød
country: Denmark
facility: Deparment of Intensive care, Nordsjællands hospital
city: Køge
country: Denmark
facility: Department of Intensive Care, Zealand University hospital
city: Randers
country: Denmark
facility: Department of Intensive Care, Regionshospitalet Randers
city: Roskilde
country: Denmark
facility: Department of Intensive Care, University Hospital Zealand, Roskilde
city: Tampere
country: Finland
facility: Department of Intensive Care, Tampere University Hospital
city: Reykjavík
country: Iceland
facility: Department of Intensive Care, Landspitali National University Hospital of Iceland
city: Mumbai
country: India
facility: Department of Anaesthesiology, Critical Care and Pain Tata Memorial Hospital, Mumbai.
city: Vilnius
country: Lithuania
facility: Department of Anaesthesia and Critical Care Vilnuis University Hospital Santariskiu Cinics, Vilnuis
city: Wellington
country: New Zealand
facility: Department of Intensive Care Wellington Hospital (CCDHB), Newton, Wellington
city: Stavanger
country: Norway
facility: Department of Intensive Care, Stavanger University Hospital
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
city: Helsingborg
country: Sweden
facility: Helsingborg Hospital
city: Bern
country: Switzerland
facility: Department of Intensive Care, Inselspital
city: Cardiff
country: United Kingdom
facility: General Adult Intensive Care Unit, Critical Care Directorate University Hospital of Wales, Cardiff
Study officials:
References: