Fluid Administration and Fluid Accumulation in the Intensive Care Unit
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNordsjaellands Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Acute admission to the ICU during the 14-day inception period.
Adults (≥ 18 years).
Disqualifiers
Patients previously included in the FLUID-ICU study.
Patients with major burns (≥ 10% of body surface)
Trial population
Adult patients admitted to the participating ICUs during the 14-inception period.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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).Secondary outcomes
1
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).2
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 days3
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 days4
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 daysOther outcomes
1
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.2
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 days3
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nordsjaellands Hospital
Lead sponsor
University of Copenhagen
Collaborator
Rigshospitalet, Denmark
Collaborator
Source ClinicalTrials.gov