Fluid Accumulation, Fluid Overload, Fluid Therapy
Conditions
Keywords
Fluid Overload, Fluid Accumulation, Fluid Administration
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.
Interventions
None listed
Sponsors
Nordsjaellands Hospital
University of Copenhagen
Rigshospitalet, Denmark
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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). |
| 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. |
Countries
Denmark, Finland, Iceland, India, Lithuania, New Zealand, Norway, Spain, Sweden, Switzerland, United Kingdom
Outcome results
None listed