An observational study in Fluid Accumulation, Fluid Therapy and Fluid Overload, sponsored by Nordsjaellands Hospital. Completed at 21 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Nordsjaellands Hospital · Observational
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.
566 studies on the registry are indexed under Edema; 95 are open to participants now.
This study's enrollment of 1,755 is above the median of 67 across 143 observational studies indexed under Edema.
Browse Edema studies →Nordsjaellands Hospital is the lead sponsor of 89 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients admitted to the participating ICUs during the 14-inception period.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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).
Time frame: From ICU admission to discharge (with a maximum of 28 days).
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.
Time frame: On the first day of ICU admission (Day 1).
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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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,
Time frame: 90 days
Mortality within 90 days from ICU admission.
Death from all causes.
Time frame: 90 days
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.
Time frame: 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).
Time frame: 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).
Time frame: Day 1-7 and after 28 days.
Ran from Apr 2024 to primary completion in May 2025, 13 months.
Of 76 non-industry observational studies under Edema, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 39. This study's 13 months is below that.
Counting every sponsor, half of 85 studies reached it within 23 months; a quarter within 7 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Nordsjaellands Hospital