Fluid Administration and Fluid Accumulation in the Intensive Care Unit
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Fluid Accumulation, Fluid Therapy, Fluid Overload. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark, Finland, Iceland, India, Lithuania +6
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Fluid Administration and Fluid Accumulation in the Intensive Care Unit (FLUID-ICU) - an International Inception Cohort Study
Overview
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.
Primary outcome measures
- The number of patients with fluid accumulation. [Time frame: From ICU admission to discharge (with a maximum of 28 days).]
Secondary outcome measures (7)
- 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]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 11 centers
- Deparment of Intensive care, Nordsjællands hospital — Hillerød
- Department of Intensive Care, Sygehus Sønderjylland Aabenraa — Aabenraa
- Departmen of Intensive Care — Aalborg
- Department of Intensive Care, University hospital Aarhus — Aarhus
- Department of Intensive Care, Rigshospitalet 4131 — Copenhagen
- Department of Intensive Care, Bispebjerg — Copenhagen
- Department of Intensive Care, Herlev Hospital — Herlev
- Department of Intensive Care, Regionshospital Gødstrup — Herning
- … and 3 more centers
Finland · 1 center
- Department of Intensive Care, Tampere University Hospital — Tampere
Iceland · 1 center
- Department of Intensive Care, Landspitali National University Hospital of Iceland — Reykjavik
India · 1 center
- Department of Anaesthesiology, Critical Care and Pain Tata Memorial Hospital, Mumbai. — Mumbai
Lithuania · 1 center
- Department of Anaesthesia and Critical Care Vilnuis University Hospital Santariskiu Cinics — Vilnius
New Zealand · 1 center
- Department of Intensive Care Wellington Hospital (CCDHB), Newton, Wellington — Wellington
Norway · 1 center
- Department of Intensive Care, Stavanger University Hospital — Stavanger
Spain · 1 center
- Hospital Clinic of Barcelona — Barcelona
Sweden · 1 center
- Helsingborg Hospital — Helsingborg
Switzerland · 1 center
- Department of Intensive Care, Inselspital — Bern
United Kingdom · 1 center
- General Adult Intensive Care Unit, Critical Care Directorate University Hospital of Wales, — Cardiff
Identifiers
NCT: NCT06258616 · FLUID-ICU