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Fluid Balance and Body Weight Changes in Critically Ill Adult Patients

Fluid Balance and Body Weight Changes in Critically Ill Adult Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04434079
Enrollment
98
Registered
2020-06-16
Start date
2018-06-01
Completion date
2018-12-01
Last updated
2020-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Fluid Overload

Keywords

Fluid Balance, Body Weight Change, Critical Illness

Brief summary

Positive fluid status has been consistently associated with worse prognosis in critically ill adult patients.However, observational studies showed poor agreement between fluid balance and body weight changes. The objective of the study is to compare the measurements of FB and BW over time and to assess correlation with ICU mortality.

Detailed description

Positive fluid status has been consistently associated with worse prognosis in critically ill adult patients. Daily and cumulative fluid balance (FB) is a routine nursing activity in intensive care unit (ICU). In view of the potential for errors in the calculation of FB totals and the problem of accounting for insensible fluid losses, measurement of body weight (BW) changes is an alternative non-invasive method commonly used for estimating body fluid status. Its accuracy over FB assumes a one kilogram change in BW equates to a one liter gain or loss in body fluid volume. However, observational studies showed poor agreement between those measurements, particularly among individuals staying more than a week in ICU possibly due to muscle and fat loss as well as bone demineralization. The objective of the study is to compare the measurements of FB and BW over time and to assess correlation with ICU mortality.

Interventions

OTHERRegular critical care

Clinical demographic data, daily and cumulative FB (input minus output) with and without insensible fluid losses, and daily and total BW changes are recorded, as well as survival outcome.

Sponsors

Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Individuals aged \>18 years-old admitted to ICU; * Expected length of ICU stay superior to 24 hours.

Exclusion criteria

* Individuals receiving oral diet; * Actual body weight superior to 227kgs or 501lb.

Design outcomes

Primary

MeasureTime frameDescription
Correlation between daily fluid balance (difference between fluid input and output during 24 hours) and the change on daily weightAt midnight every 24 hours up to patient's ICU discharge or up to 6 months, whichever comes first.Correlation between daily fluid balance and weight change (Bland-Altman agreement test)

Secondary

MeasureTime frameDescription
Correlation between cumulative fluid balance and total weight changeLast day of each patient's ICU hospitalization, up to 6 monthsCorrelation between cumulative fluid balance and total weight change (Bland-Altman)
Discriminative power of fluid balance in predicting ICU mortalityThrough study completion, up to 6 monthsArea under ROC curve for fluid balance (L). ICU mortality as reference variable.
Discriminative power of body weight changes in predicting ICU mortalityThrough study completion, up to 6 monthsArea under ROC curve for body weight change (kg). ICU mortality as reference variable.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026