Fluid Balance and Body Weight Changes in Critically Ill Adult Patients

NCT04434079 | Completed

• 1 other identifier: 2018-0486
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Fluid Overload

Keywords

Fluid Balance; Body Weight Change; Critical Illness

Outcome Measures

Primary Outcomes (1)

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

  Correlation between daily fluid balance and weight change (Bland-Altman agreement test)

  At midnight every 24 hours up to patient's ICU discharge or up to 6 months, whichever comes first.

Secondary Outcomes (3)

• Correlation between cumulative fluid balance and total weight change

  Last day of each patient's ICU hospitalization, up to 6 months

• Discriminative power of fluid balance in predicting ICU mortality

  Through study completion, up to 6 months

• Discriminative power of body weight changes in predicting ICU mortality

  Through study completion, up to 6 months

Study Arms (1)

Included individuals

Adult patients consecutively admitted to the ICU from June to October 2018 are eligible if expected length of stay is superior to 24 hours and no oral nutritional has been offered.

Other: Regular critical care

Interventions

Regular critical care OTHER

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.

Included individuals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Critical Illness; Edema; Body Weight Changes

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Body Weight

Study Officials

• Ana Carolina P Antonio, MD, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 16, 2020
• Study Start: June 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

BR (1)