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NCT Number: NCT06258616

Fluid Administration and Fluid Accumulation in the Intensive Care Unit

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.

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Key information

Conditions

Fluid Accumulation Edema Fluid Overload Fluid Therapy Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Deparment of Intensive care, Nordsjællands hospital, Hillerød, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. The number of patients with fluid accumulation.

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

    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).

Secondary outcomes

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

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

    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.

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

    Time frame: 28 days

    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).

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

    Time frame: 28 days

    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.

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

    Time frame: 28 days

    Defined as patients that receive treatment with any type of diuretics or renal replacement therapy.

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

    Time frame: 28 days

    Days alive without use of life-support (continuous infusion of vasopressors/inotropes, invasive mechanical ventilation or renal replacement therapy).

  6. Days alive and out of hospital within 90 days from ICU admission.

    Time frame: 90 days

    Total number of days alive and out of hospital within 90 days from ICU admission,

  7. Mortality within 90 days from ICU admission.

    Time frame: 90 days

    Death from all causes.

Other outcomes

  1. 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.

    Time frame: Day 1-7 and after 28 days.

    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.

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

    Time frame: Day 1-7 and after 28 days

    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).

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

    Time frame: Day 1-7 and after 28 days.

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Clara Molin, MD, PhD student

CONTACT

[email protected]

+4528683965

Morten Bestle, Professor, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Collaborators

  • Rigshospitalet, Denmark
  • University of Copenhagen

Registry information

Official study title

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

Acronym: FLUID-ICU

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 14, 2024
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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