Fluid Overload Clinical Trial
— FLUID-ICUOfficial title:
Fluid Administration and Fluid Accumulation in the Intensive Care Unit (FLUID-ICU) - an International Inception Cohort Study
NCT number | NCT06258616 |
Other study ID # | FLUID-ICU |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2024 |
Est. completion date | August 2025 |
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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | August 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Denmark | 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, Bispebjerg | Copenhagen | |
Denmark | Department of Intensive Care, Rigshospitalet 4131 | 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 | |
Finland | Department of Intensive Care, Tampere University Hospital | Tampere | |
Iceland | Department of Intensive Care, Landspitali National University Hospital of Iceland | Reykjavík | |
India | Department of Anaesthesiology, Critical Care and Pain Tata Memorial Hospital, Mumbai. | Mumbai | |
Lithuania | Department of Anaesthesia and Critical Care Vilnuis University Hospital Santariskiu Cinics, Vilnuis | Vilnius | |
New Zealand | Department of Intensive Care Wellington Hospital (CCDHB), Newton, Wellington | Wellington | |
Norway | Department of Intensive Care, Stavanger University Hospital | Stavanger | |
Switzerland | Department of Intensive Care, Inselspital | Bern | |
United Kingdom | General Adult Intensive Care Unit, Critical Care Directorate University Hospital of Wales, Cardiff | Cardiff |
Lead Sponsor | Collaborator |
---|---|
Nordsjaellands Hospital | Rigshospitalet, Denmark, University of Copenhagen |
Denmark, Finland, Iceland, India, Lithuania, New Zealand, Norway, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | Definition: the median volume of all fluid in millilitres (mL) administered during ICU admission categorized by indication (resuscitation, maintenance-replacement, fluid creep, nutrition, blood products) reported on day 1, 2, 3, 4, 5, 6, 7 and 28 days after ICU admission. | Day 1-7 and after 28 days. | |
Other | Fluid balance (mL) during ICU stay on day 1-7 and 28 days after ICU admission | Definition: The sum of all daily fluid inputs minus all daily fluid outputs reported on day 1, 2, 3, 4, 5, 6, 7 and 28 days after ICU admission in mL (median). | Day 1-7 and after 28 days | |
Other | Cumulative fluid balance (mL) day 1-7 and 28 days after ICU admission | Definition: Cumulative fluid balance will be calculated as the sum of all fluid input minus all fluid output reported on day 1, 2, 3, 4, 5, 6, 7 and 28 days after ICU admission in mL (median). | Day 1-7 and after 28 days. | |
Primary | The number of patients with fluid accumulation. | 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). | From ICU admission to discharge (with a maximum of 28 days). | |
Secondary | Number of patients with fluid accumulation upon ICU admission (baseline). | 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. | On the first day of ICU admission (Day 1). | |
Secondary | Number of patients developing fluid accumulation during the ICU stay. | 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). | 28 days | |
Secondary | Number of days with fluid accumulation during the ICU stay. | 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. | 28 days | |
Secondary | Number of patients being treated with 'active fluid removal' (use of diuretics, or renal replacement therapy). | Defined as patients that receive treatment with any type of diuretics or renal replacement therapy. | 28 days | |
Secondary | Days alive without use of life-support within 28 days from ICU admission. | Days alive without use of life-support (continuous infusion of vasopressors/inotropes, invasive mechanical ventilation or renal replacement therapy). | 28 days | |
Secondary | Days alive and out of hospital within 90 days from ICU admission. | Total number of days alive and out of hospital within 90 days from ICU admission, | 90 days | |
Secondary | Mortality within 90 days from ICU admission. | Death from all causes. | 90 days |
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