Fluid Administration and Fluid Accumulation in the Intensive Care Unit

NCT06258616 | Recruiting

• 1 other identifier: FLUID-ICU
• Study Type: observational
• Target: 1,000
• Locations: 11 countries
• Sites: 21

Brief 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.

Conditions

Fluid Accumulation; Fluid Therapy; Fluid Overload

Keywords

Fluid Overload; Fluid Accumulation; Fluid Administration

Outcome Measures

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).

  From ICU admission to discharge (with a maximum of 28 days).

Secondary Outcomes (7)

• Number of patients with fluid accumulation upon ICU admission (baseline).

  On the first day of ICU admission (Day 1).

• Number of patients developing fluid accumulation during the ICU stay.

  28 days

• Number of days with fluid accumulation during the ICU stay.

  28 days

• Number of patients being treated with 'active fluid removal' (use of diuretics, or renal replacement therapy).

  28 days

• Days alive without use of life-support within 28 days from ICU admission.

  28 days

Other Outcomes (3)

• 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.

  Day 1-7 and after 28 days.

• Fluid balance (mL) during ICU stay on day 1-7 and 28 days after ICU admission

  Day 1-7 and after 28 days

• Cumulative fluid balance (mL) day 1-7 and 28 days after ICU admission

  Day 1-7 and after 28 days.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Acute admission to the ICU during the 14-day inception period.
• Adults (≥ 18 years).

You may not qualify if:

• Patients previously included in the FLUID-ICU study.
• Patients with major burns (≥ 10% of body surface)

Sponsors & Collaborators

• Nordsjaellands Hospital: lead
• University of Copenhagen: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (21)

Deparment of Intensive care, Nordsjællands hospital

Hillerød, Hillerød, 3400, Denmark

COMPLETED

Department of Intensive Care, Sygehus Sønderjylland Aabenraa

Aabenraa, Denmark

NOT YET RECRUITING

Departmen of Intensive Care

Aalborg, 9000, Denmark

ACTIVE NOT RECRUITING

Department of Intensive Care, University hospital Aarhus

Aarhus, Denmark

NOT YET RECRUITING

Department of Intensive Care, Rigshospitalet 4131

Copenhagen, 2100, Denmark

RECRUITING

Department of Intensive Care, Bispebjerg

Copenhagen, 7100, Denmark

RECRUITING

Department of Intensive Care, Herlev Hospital

Herlev, 2730, Denmark

COMPLETED

Department of Intensive Care, Regionshospital Gødstrup

Herning, 7400, Denmark

ACTIVE NOT RECRUITING

Department of Intensive Care, Zealand University hospital

Køge, 4600, Denmark

COMPLETED

Department of Intensive Care, Regionshospitalet Randers

Randers, 8930, Denmark

ACTIVE NOT RECRUITING

Department of Intensive Care, University Hospital Zealand, Roskilde

Roskilde, Denmark

COMPLETED

Department of Intensive Care, Tampere University Hospital

Tampere, 33520, Finland

ACTIVE NOT RECRUITING

Department of Intensive Care, Landspitali National University Hospital of Iceland

Reykjavik, Iceland

COMPLETED

Department of Anaesthesiology, Critical Care and Pain Tata Memorial Hospital, Mumbai.

Mumbai, India

NOT YET RECRUITING

Department of Anaesthesia and Critical Care Vilnuis University Hospital Santariskiu Cinics, Vilnuis

Vilnius, Lithuania

ACTIVE NOT RECRUITING

Department of Intensive Care Wellington Hospital (CCDHB), Newton, Wellington

Wellington, New Zealand

COMPLETED

Department of Intensive Care, Stavanger University Hospital

Stavanger, 4068, Norway

ACTIVE NOT RECRUITING

Hospital Clinic of Barcelona

Barcelona, Spain

RECRUITING

Helsingborg Hospital

Helsingborg, Sweden

ACTIVE NOT RECRUITING

Department of Intensive Care, Inselspital

Bern, Switzerland

COMPLETED

General Adult Intensive Care Unit, Critical Care Directorate University Hospital of Wales, Cardiff

Cardiff, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Clara Molin, MD, PhD student

CONTACT

+4528683965; claramolinmolin@gmail.com

Morten Bestle, Professor, MD, PhD

CONTACT

morten.bestle@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 14, 2024
• Study Start: April 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (11); IC (1); LI (1); NZ (1); NO (1); ES (1); SE (1); FI (1); GB (1); IN (1); CH (1)