Fluid Administration and Fluid Accumulation in the Intensive Care Unit (FLUID-ICU)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Fluid Therapy; Fluid Overload; Fluid Accumulation

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Clara Molin, MD, PhD student; Phone Number: +4528683965; Email: claramolinmolin@gmail.com
• Study Contact Backup: Name: Morten Bestle, Professor, MD, PhD; Email: morten.bestle@regionh.dk

Study Locations

• Denmark
  • Aabenraa, Denmark
    • Not yet recruiting
    • Department of Intensive Care, Sygehus Sønderjylland Aabenraa
    • Contact: Thomas Strøm, Professor
  • Aalborg, Denmark, 9000
    • Active, not recruiting
    • Departmen of Intensive Care
  • Aarhus, Denmark
    • Not yet recruiting
    • Department of Intensive Care, University hospital Aarhus
    • Contact: Steffen Christensen
    • Contact: Mette Jørgensen
    • Contact: Eva Nielsen
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Department of Intensive Care, Rigshospitalet 4131
    • Contact: Maj-Brit Nørregaard
  • Copenhagen, Denmark, 7100
    • Recruiting
    • Department of Intensive Care, Bispebjerg
    • Contact: I
    • Contact: Theis Itenov, MD, PhD
  • Herlev, Denmark, 2730
    • Completed
    • Department of Intensive Care, Herlev Hospital
  • Herning, Denmark, 7400
    • Active, not recruiting
    • Department of Intensive Care, Regionshospital Gødstrup
  • Hillerød, Denmark, 3400
    • Completed
    • Deparment of Intensive care, Nordsjællands hospital
  • Køge, Denmark, 4600
    • Completed
    • Department of Intensive Care, Zealand University hospital
  • Randers, Denmark, 8930
    • Active, not recruiting
    • Department of Intensive Care, Regionshospitalet Randers
  • Roskilde, Denmark
    • Completed
    • Department of Intensive Care, University Hospital Zealand, Roskilde
• Finland
  • Tampere, Finland, 33520
    • Active, not recruiting
    • Department of Intensive Care, Tampere University Hospital
• Iceland
  • Reykjavík, Iceland
    • Completed
    • Department of Intensive Care, Landspitali National University Hospital of Iceland
• India
  • Mumbai, India
    • Not yet recruiting
    • Department of Anaesthesiology, Critical Care and Pain Tata Memorial Hospital, Mumbai.
    • Contact: Sheila Myatra
• Lithuania
  • Vilnius, Lithuania
    • Active, not recruiting
    • Department of Anaesthesia and Critical Care Vilnuis University Hospital Santariskiu Cinics, Vilnuis
• New Zealand
  • Wellington, New Zealand
    • Completed
    • Department of Intensive Care Wellington Hospital (CCDHB), Newton, Wellington
• Norway
  • Stavanger, Norway, 4068
    • Active, not recruiting
    • Department of Intensive Care, Stavanger University Hospital
• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Clinic of Barcelona
    • Contact: Pedro Castro
• Sweden
  • Helsingborg, Sweden
    • Active, not recruiting
    • Helsingborg Hospital
• Switzerland
  • Bern, Switzerland
    • Completed
    • Department of Intensive Care, Inselspital
• United Kingdom
  • Cardiff, United Kingdom
    • Not yet recruiting
    • General Adult Intensive Care Unit, Critical Care Directorate University Hospital of Wales, Cardiff
    • Contact: Matt Wise, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to the participating ICUs during the 14-inception period.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality within 90 days from ICU admission.	Death from all causes.	90 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
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).
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

Other Outcome Measures

Outcome Measure	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.	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.

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Collaborators: Rigshospitalet, Denmark; University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Fluid Overload; Fluid Accumulation; Fluid Administration
• Other Study ID Numbers: FLUID-ICU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No