Clinical trial NCT04434079: Fluid Balance and Body Weight Changes in Critically Ill Adult Patients
Official title: Fluid Balance and Body Weight Changes in Critically Ill Adult Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Fluid Overload
Keywords: Fluid Balance
Body Weight Change
Critical Illness
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients consecutively admitted to the ICU from June to October 2018 are eligible if expected length of ICU stay is superior to 24 hours and no oral nutritional is being offered.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Correlation between daily fluid balance (difference between fluid input and output during 24 hours) and the change on daily weight
timeFrame: At midnight every 24 hours up to patient's ICU discharge or up to 6 months, whichever comes first.
Secondary outcomes:
measure: Correlation between cumulative fluid balance and total weight change
timeFrame: Last day of each patient's ICU hospitalization, up to 6 months
measure: Discriminative power of fluid balance in predicting ICU mortality
timeFrame: Through study completion, up to 6 months
measure: Discriminative power of body weight changes in predicting ICU mortality
timeFrame: Through study completion, up to 6 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Ana Carolina P Antonio, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: