Fluid Administration and Fluid Accumulation in the Intensive Care Unit
- Conditions
- Fluid AccumulationFluid TherapyFluid Overload
- Registration Number
- NCT06258616
- Lead Sponsor
- Nordsjaellands Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- Acute admission to the ICU during the 14-day inception period.
- Adults (≥ 18 years).
- Patients previously included in the FLUID-ICU study.
- Patients with major burns (≥ 10% of body surface)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of patients with fluid accumulation. From ICU admission to discharge (with a maximum of 28 days). 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).
- Secondary Outcome Measures
Name Time Method Number of patients developing fluid accumulation during the ICU stay. 28 days 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).
Number of days with fluid accumulation during the ICU stay. 28 days 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.
Days alive and out of hospital within 90 days from ICU admission. 90 days Total number of days alive and out of hospital within 90 days from ICU admission,
Mortality within 90 days from ICU admission. 90 days Death from all causes.
Number of patients with fluid accumulation upon ICU admission (baseline). On the first day of ICU admission (Day 1). 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.
Number of patients being treated with 'active fluid removal' (use of diuretics, or renal replacement therapy). 28 days Defined as patients that receive treatment with any type of diuretics or renal replacement therapy.
Days alive without use of life-support within 28 days from ICU admission. 28 days Days alive without use of life-support (continuous infusion of vasopressors/inotropes, invasive mechanical ventilation or renal replacement therapy).
Trial Locations
- Locations (21)
Department of Intensive Care, Sygehus Sønderjylland Aabenraa
🇩🇰Aabenraa, Denmark
Departmen of Intensive Care
🇩🇰Aalborg, Denmark
Department of Intensive Care, University hospital Aarhus
🇩🇰Aarhus, Denmark
Department of Intensive Care, Rigshospitalet 4131
🇩🇰Copenhagen, Denmark
Department of Intensive Care, Bispebjerg
🇩🇰Copenhagen, Denmark
Department of Intensive Care, Herlev Hospital
🇩🇰Herlev, Denmark
Department of Intensive Care, Regionshospital Gødstrup
🇩🇰Herning, Denmark
Deparment of Intensive care, Nordsjællands hospital
🇩🇰Hillerød, Denmark
Department of Intensive Care, Zealand University hospital
🇩🇰Køge, Denmark
Department of Intensive Care, Regionshospitalet Randers
🇩🇰Randers, Denmark
Department of Intensive Care, University Hospital Zealand, Roskilde
🇩🇰Roskilde, Denmark
Department of Intensive Care, Tampere University Hospital
🇫🇮Tampere, Finland
Department of Intensive Care, Landspitali National University Hospital of Iceland
🇮🇸Reykjavík, Iceland
Department of Anaesthesiology, Critical Care and Pain Tata Memorial Hospital, Mumbai.
🇮🇳Mumbai, India
Department of Anaesthesia and Critical Care Vilnuis University Hospital Santariskiu Cinics, Vilnuis
🇱🇹Vilnius, Lithuania
Department of Intensive Care Wellington Hospital (CCDHB), Newton, Wellington
🇳🇿Wellington, New Zealand
Department of Intensive Care, Stavanger University Hospital
🇳🇴Stavanger, Norway
Hospital Clinic of Barcelona
🇪🇸Barcelona, Spain
Helsingborg Hospital
🇸🇪Helsingborg, Sweden
Department of Intensive Care, Inselspital
🇨🇭Bern, Switzerland
General Adult Intensive Care Unit, Critical Care Directorate University Hospital of Wales, Cardiff
🇬🇧Cardiff, United Kingdom