NCT06258616

Fluid Administration and Fluid Accumulation in the Intensive Care Unit

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Nordsjaellands Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Fluid Accumulation
• Fluid Therapy
• Fluid Overload

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-05-01
• Completion: 2025-09-01
• First posted: 2024-02-14
• Last updated: 2025-02-06

Locations

21 sites across 11 countries: Denmark, Finland, Iceland, India, Lithuania, New Zealand, Norway, Spain, Sweden, Switzerland, United Kingdom