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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date January 2024
Source Nordsjaellands Hospital
Contact Clara Molin, MD, PhD student
Phone +4528683965
Email claramolinmolin@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Locations

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

Sponsors (3)

Lead Sponsor Collaborator
Nordsjaellands Hospital Rigshospitalet, Denmark, University of Copenhagen

Countries where clinical trial is conducted

Denmark,  Finland,  Iceland,  India,  Lithuania,  New Zealand,  Norway,  Switzerland,  United Kingdom, 

Outcome

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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