Fluid Administration and Fluid Accumulation in the Intensive Care Unit

Fluid Overload Clinical Trial

— FLUID-ICU  

Official title:

Fluid Administration and Fluid Accumulation in the Intensive Care Unit (FLUID-ICU) - an International Inception Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06258616
• Other study ID #: FLUID-ICU
• Status: Recruiting
• 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
• 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
• 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)

Related Conditions & MeSH terms

• Fluid Overload
• Fluid Therapy

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