Fluid Administration and Fluid Accumulation in the Intensive Care Unit

NCT ID: NCT06258616

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fluid Accumulation Fluid Therapy Fluid Overload

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Nordsjaellands Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Deparment of Intensive care, Nordsjællands hospital

Hillerød, Hillerød, Denmark

Site Status COMPLETED

Department of Intensive Care, Sygehus Sønderjylland Aabenraa

Aabenraa, , Denmark

Site Status NOT_YET_RECRUITING

Departmen of Intensive Care

Aalborg, , Denmark

Site Status ACTIVE_NOT_RECRUITING

Department of Intensive Care, University hospital Aarhus

Aarhus, , Denmark

Site Status NOT_YET_RECRUITING

Department of Intensive Care, Rigshospitalet 4131

Copenhagen, , Denmark

Site Status RECRUITING

Department of Intensive Care, Bispebjerg

Copenhagen, , Denmark

Site Status RECRUITING

Department of Intensive Care, Herlev Hospital

Herlev, , Denmark

Site Status COMPLETED

Department of Intensive Care, Regionshospital Gødstrup

Herning, , Denmark

Site Status ACTIVE_NOT_RECRUITING

Department of Intensive Care, Zealand University hospital

Køge, , Denmark

Site Status COMPLETED

Department of Intensive Care, Regionshospitalet Randers

Randers, , Denmark

Site Status ACTIVE_NOT_RECRUITING

Department of Intensive Care, University Hospital Zealand, Roskilde

Roskilde, , Denmark

Site Status COMPLETED

Department of Intensive Care, Tampere University Hospital

Tampere, , Finland

Site Status ACTIVE_NOT_RECRUITING

Department of Intensive Care, Landspitali National University Hospital of Iceland

Reykjavik, , Iceland

Site Status COMPLETED

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

Mumbai, , India

Site Status NOT_YET_RECRUITING

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

Vilnius, , Lithuania

Site Status ACTIVE_NOT_RECRUITING

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

Wellington, , New Zealand

Site Status COMPLETED

Department of Intensive Care, Stavanger University Hospital

Stavanger, , Norway

Site Status ACTIVE_NOT_RECRUITING

Hospital Clinic of Barcelona

Barcelona, , Spain

Site Status RECRUITING

Helsingborg Hospital

Helsingborg, , Sweden

Site Status ACTIVE_NOT_RECRUITING

Department of Intensive Care, Inselspital

Bern, , Switzerland

Site Status COMPLETED

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

Cardiff, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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Denmark Finland Iceland India Lithuania New Zealand Norway Spain Sweden Switzerland United Kingdom

Central Contacts

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Clara Molin, MD, PhD student

Role: CONTACT

+4528683965

Morten Bestle, Professor, MD, PhD

Role: CONTACT

Facility Contacts

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Steffen Christensen

Role: primary

I

Role: primary

Pedro Castro

Role: primary

Other Identifiers

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FLUID-ICU

Identifier Type: -

Identifier Source: org_study_id

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