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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| Rigshospitalet, Denmark | OTHER |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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Adult patients admitted to the participating ICUs during the 14-inception period.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clara Molin, MD, PhD student | Contact | +4528683965 | claramolinmolin@gmail.com | |
| Morten Bestle, Professor, MD, PhD | Contact | morten.bestle@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deparment of Intensive care, Nordsjællands hospital | Completed | Hillerød | Hillerød | 3400 | Denmark | |
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| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Mortality within 90 days from ICU admission. | Death from all causes. | 90 days |
| Day 1-7 and after 28 days. |
| 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 |
| 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. |
| Department of Intensive Care, Sygehus Sønderjylland Aabenraa |
| Not yet recruiting |
| Aabenraa |
| Denmark |
|
| Departmen of Intensive Care | Active, not recruiting | Aalborg | 9000 | Denmark |
| Department of Intensive Care, University hospital Aarhus | Not yet recruiting | Aarhus | Denmark |
|
| Department of Intensive Care, Rigshospitalet 4131 | Recruiting | Copenhagen | 2100 | Denmark |
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| Department of Intensive Care, Bispebjerg | Recruiting | Copenhagen | 7100 | Denmark |
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| Department of Intensive Care, Herlev Hospital | Completed | Herlev | 2730 | Denmark |
| Department of Intensive Care, Regionshospital Gødstrup | Active, not recruiting | Herning | 7400 | Denmark |
| Department of Intensive Care, Zealand University hospital | Completed | Køge | 4600 | Denmark |
| Department of Intensive Care, Regionshospitalet Randers | Active, not recruiting | Randers | 8930 | Denmark |
| Department of Intensive Care, University Hospital Zealand, Roskilde | Completed | Roskilde | Denmark |
| Department of Intensive Care, Tampere University Hospital | Active, not recruiting | Tampere | 33520 | Finland |
| Department of Intensive Care, Landspitali National University Hospital of Iceland | Completed | Reykjavik | Iceland |
| Department of Anaesthesiology, Critical Care and Pain Tata Memorial Hospital, Mumbai. | Not yet recruiting | Mumbai | India |
|
| Department of Anaesthesia and Critical Care Vilnuis University Hospital Santariskiu Cinics, Vilnuis | Active, not recruiting | Vilnius | Lithuania |
| Department of Intensive Care Wellington Hospital (CCDHB), Newton, Wellington | Completed | Wellington | New Zealand |
| Department of Intensive Care, Stavanger University Hospital | Active, not recruiting | Stavanger | 4068 | Norway |
| Hospital Clinic of Barcelona | Recruiting | Barcelona | Spain |
|
| Helsingborg Hospital | Active, not recruiting | Helsingborg | Sweden |
| Department of Intensive Care, Inselspital | Completed | Bern | Switzerland |
| General Adult Intensive Care Unit, Critical Care Directorate University Hospital of Wales, Cardiff | Not yet recruiting | Cardiff | United Kingdom |
|
| ID | Term |
|---|---|
| D004487 | Edema |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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