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Clinical Trials/NCT04434079
NCT04434079
Completed
Not Applicable

Fluid Balance and Body Weight Changes in Critically Ill Adult Patients

Hospital de Clinicas de Porto Alegre1 site in 1 country98 target enrollmentJune 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Illness
Sponsor
Hospital de Clinicas de Porto Alegre
Enrollment
98
Locations
1
Primary Endpoint
Correlation between daily fluid balance (difference between fluid input and output during 24 hours) and the change on daily weight
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
December 1, 2018
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Correlation between daily fluid balance (difference between fluid input and output during 24 hours) and the change on daily weight

Time Frame: At 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 Outcomes

  • Discriminative power of fluid balance in predicting ICU mortality(Through study completion, up to 6 months)
  • Correlation between cumulative fluid balance and total weight change(Last day of each patient's ICU hospitalization, up to 6 months)
  • Discriminative power of body weight changes in predicting ICU mortality(Through study completion, up to 6 months)

Study Sites (1)

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